EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, 21.4.2021  
COM(2021) 202 final  
2021/0105 (COD)  
 
Proposal for a  
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
on machinery products  
(Text with EEA relevance)  
{SEC(2021)  165 final}  - {SWD(2021)  82 final}  - {SWD(2021)  83 final}   EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL  
1.1. Reasons for and objectives of the proposal  
The Machinery Directive (hereafter ‘MD’)1 establishes a regulatory framework for placing 
machinery on the Single Market, based on Article 114 of the TFEU (the approximation of 
laws. The general objectives of the MD are to: i) ensure free movement of machinery within 
the internal market; and ii) en sure a high level of protection for users and other exposed 
persons. The MD follows the ‘new approach’ principles of EU legislation. It is intentionally 
written to be technology neutral, which means that it lays down the essential health and safety 
require ments (hereafter ‘safety requirements’) to be complied with, without prescribing any 
specific technical solution to comply with those requirements. The choice of the technical 
solution is a prerogative of manufacturers, which leaves space for innovation an d new design 
development.  
During the REFIT evaluation2 of the directive, all interested parties confirmed it is an 
essential piece of legislation although it identified a necessity to improve, simplify and adapt 
the MD to the needs of the market. Some Mem bers of the European Parliament’s expressed 
their support to the revision of the Machinery Directive. In particular, by ‘taking the 
legislation’ to the XXI century and promoting innovation for the EU economy.  
As part of the Commission Work Programme 2020 under the priority ‘A Europe fit for the 
Digital Age’, the revision of the product safety Directive 2006/42/EC on Machinery (MD)3 
contributes to the digital transition and to the strengthening of the Single Market. Indeed, 
regarding new technologies and th eir impact on safety legislation, the Commission has 
published in February 2020 a White Paper on Artificial Intelligence accompanied by a 
‘Report on the safety and liability implications of Artificial Intelligence, the Internet of 
Things and robotics’4. The Report, which has conducted an analysis of the impact of new 
technologies and the challenges they pose to Union safety legislation, concluded that the 
current product safety legislation contains a number of gaps that need to be addressed, in 
particular, among other, in the Machinery Directive. This is even more relevant for a 
sustainable recovery from the COVID pandemic, since the machinery sector is an essential 
part of the engineering industry and one of the industrial mainstays of the EU economy.  
In view of dealing with the elements highlighted in the evaluation and developed in the 
impact assessment report of the machinery directive5, as well as responding  to the 
Commission policy objectives on digitalization, this proposal expects to tackle the follo wing 
problems:  
Problem 1 : The MD does not sufficiently cover new risks originating from emerging 
technologies.  
                                                 
 
1 Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery.  
2 SWD (2018) 160 final, Evaluation of the Machinery Directive.  
3 Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery.  
4 Available at: https://ec.europa.eu/info/publications/commission -report -safety -and-liability -implica tions -
ai-internet -things -and-robotics -0_en   
5 SWD (2021) […] final, Impact assessment of the Machinery Directive.  EN 2  EN In order to boost the trust in digital technologies, the MD needs to provide legal certainty as 
regards those technologies, existing gaps could  hinder a level playing field for manufacturers, 
which would impact the efficiency of the MD.  
There are several aspects that need to be addressed within this problem. The first one relates 
to the potential risks that originate from a direct human -robot co llaboration  as the 
collaborative robots (co -bots) that are designed to work alongside human and employees are 
exponentially increasing. A second source of potential risk originates from connected 
machinery . A third area of concern lies with the way softwar e updates affects the ‘behaviour’ 
of the machinery after its placing on the market . A fourth  concern relates to the ability of 
manufacturers to conduct a full risk assessment on machine learning applications before the 
product is placed on the market.  Finally, as far as the autonomous machines and remote 
supervisory stations, the current MD foresees a driver or an operator responsible for the 
movement of a machine. The driver may be transported by the machinery or may be 
accompanying the machinery, or may guide the machinery by remote control, but does not 
consider the possibility of no driver, and sets up no requirements for autonomous machines.  
Problem 2 : (i) Legal uncertainty due to a lack of clarity on the scope and definitions; and (ii) 
possible safet y gaps in traditional technologies.  
The MD needs greater legal certainty in its scope and definitions, which generated some 
difficulties for manufacturers to understand the correct legal framework they should apply. 
Some overlaps or inconsistencies with other EU specific legislation were ide ntified. With 
respect to the definitions set by the Directive, the definition of 'partly completed machinery' 
raised a number of concerns particularly centred at the borderline with the definition of 
'machinery' and the definition of ‘machinery’ has been c larified. Besides, there is a need to 
clarify the exclusion of means of transport and to reinforce the coherence of the exclusion of 
some products covered by the Low Voltage Directive  2014/35/EU6 when those products 
integrate a Wi -Fi function.  
Furthermore , it is a common practice that machines placed on the market are modified in 
order for example to add a function or improve the performance. The problem is that if the 
machine suffers a substantial modification, without the manufacturer’s agreement,  may be  
not in conformity any longer with the essential health and safety requirements. The current 
MD does not address this situation.  
There are a number of requirements on traditional technologies  not related to new 
technologies that were identified either as not clear or safe enough, or as too prescriptive and 
potentially hindering innovation. These requirements are related to installation of lifting 
appliances, slow speed lifts, seating, protection against hazardous substances, overhead power 
lines and vibrat ion from portable handheld and hand guided machinery.    
Problem 3 : Insufficient provisions for high risk machines.  
The third party conformity assessment is considered by some Member States and stakeholders 
more adapted to address the high risks stemming from certain groups of machines.  
                                                 
 
6 Directive 2014/35/EU of the European Parliament and of the Council of 26  February 2014 on the 
harmonisation of the laws of the Member State s relating to the making available on the market of 
electrical equipment designed for use within certain voltage limits, available at: 
http://d ata.europa.eu/eli/dir/2014/35/oj . EN 3  EN Another problem is that the current list of high -risk machines in Annex I was elaborated 
15 years ago , and the market has much evolved since then. It is necessary to remove 
machines no longer considered high risk and/or introducing new ones (such as machinery 
embedding AI systems, which fulfil a safety function).  
Problem 4 : Monetary and environmental cos ts due to extensive paper -based documentation.  
The MD requires manufacturers to provide the necessary machinery information, such as 
instructions. To ensure that every machine user has access to the instructions, providing a 
printed version was considered as the most viable option. Since then, however, the use of the 
internet and digital technologies has increased. The requirement to provide printed versions 
increases the costs and administrative burdens for economic operators and has a negative 
impact on t he environment. However, it must be also considered that some users are less 
digitally savvy, there is a lack of internet access in certain environments and the digital 
manual might not match the version of the product.  
Problem 5 : Inconsistencies with othe r pieces of Union product safety legislation.  
The New Legislative Framework is a package of measures aimed at brought together all the 
elements required for a comprehensive regulatory framework to operate effectively for the 
safety and compliance of indust rial products with the requirements adopted to protect the 
various public interests and for the proper functioning of the single market. A main objective 
of the Commission is to bring product harmonisation legislation in line with the reference 
provisions of Decision 768/2008/EC. While the Machinery Directive is already a New 
Approach directive, it is not yet aligned to the NLF.  
The lack of MD’s alignment to the NLF creates inconsistencies with other EU product 
legislation.  
Problem 6 : Divergences in inter pretation due to transposition.  
The fact that the current machinery legislation is a Directive leaving Member States to choose 
the means to comply with the legislative objectives, has led to different interpretations of the 
MD provisions creating legal un certainty and lack of coherence throughout the single market. 
Furthermore, there have been delays in the transposition of the Directive in some Member 
States.  
1.2. Consistency with existing policy provisions in the policy area  
This initiative is in line with the Single Market Act7, which stressed the need to restore 
consumer confidence in the quality of products on the market and the importance of 
reinforcing market surveillance. With this purpose, the regulation on machinery products is 
aligned to the pr ovisions of Decision No 768/2008/EC8.  
Furthemore it reinforces the coherence with the low voltage directive 2014/35/EU9 by 
considering the fact that electrical and electronic products excluded from this Regulation will 
                                                 
 
7 Communication from the Commission to the European Parliament, the Council, the Economic and 
Social Committee and the Committee of the Regions (COM(2011) 206 final).  
8 Decision No 768/2008/EC of the European Parliament a nd of the Council of 9 July 2008 on a common 
framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 
13.08.2008, p. 82).  
9 Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the 
harmonisation of the laws of the Member States relating to the making available on the market of 
electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 35).  EN 4  EN be also excluded from the radio equi pment directive 2014/53/EU10 when they incorporate wi -
fi.  
1.3. Consistency with other Union policies  
This proposal is coherent with the Union policy on artificial intelligence (AI) and the 
upcoming Regulation on artificial intelligence, which will address the risks having an impact 
on safety for high -risk AI systems embedded in a machinery or that are safety components 
under the  future regulation on machinery products.  
In addition, this proposal is coherent with the Union policy on cybersecurity, making the link 
with the future cybersecurity schemes pursuant to Regulation (EU) 2019/881 for the purpose 
of demonstrating compliance with the future regulation on machinery pr oducts.  
Furthermore it contributes to simplification of the regulatory environment.  
2. LEGAL  BASIS,  SUBSIDIARITY  AND  PROPORTIONALITY  
2.1. Legal  basis  
The proposal is based on Article 114 of the Treaty on the Functioning of the European Union 
because the purpose of the Regulation is to harmonise health and safety requirements for 
machinery in all Member States and to remove obstacles to trade in machinery between 
Member States.  
2.2. Subsidiarity  (for non-exclusive  competence)   
The subsidiarity principle a rises in particular with regard to the newly added provisions 
aiming at the improvement of effective enforcement of Directive 2006/42/EC and the 
coherence with the AI Union policy. Without a Union wide regulation, Member States could 
impose diverging safet y requirements, which would lead to differences in the safety of the 
products for the users for manufacturers when trading machinery across different countries. 
For instance, some market surveillance authorities consulted found necessary to ensure that 
software updates not foreseen in the initial manufacturer’s risks assessment and having an 
impact on safety would require the machine to go through a conformity assessment procedure 
leading to a new CE marking. Furthermore, the future regulation on machinery products sets 
up Union wide requirements underpinned by the solutions provided in European standards. 
Given the Union broad level of the standardisations activities, any changes to the scope or 
requirements of the future regulation on machinery products mu st be made at Union level to 
avoid distorting the market, creating barriers to the free movement of products and 
undermining the protection of human health and well -being. In addition, the newly added 
provisions will align the economic operators’ obligatio ns, the traceability provisions, the 
provisions on the assessment and notification of conformity assessment bodies and on market 
surveillance.  
As for the added value of action at Union level, regulatory action at the Union level, 
contributes to the develo pment of the Internal (and Digital) Single Market, provides legal 
certainty and a level playing field for the industry, and establishes a high level of trust among 
machinery users.  
                                                 
 
10 Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the 
harmonisation of the laws of the Member States relating to the making available on the market of radio 
equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62).  EN 5  EN 2.3. Proportionality  
The preferred policy option is option 3 - Burden minimisation and enhanced safety.   
This policy option addresses all identified problems in the most effective and efficient way, 
proposing a revised MD that is not only fit for purpose now, but also in the years to come, and 
ensures coherence with existing  product safety legislation and with the future AI framework.  
Policy option 3 adds new requirements and clarifies existing ones, in a targeted and 
proportional way, only when necessary and often applicable to certain types of machinery. 
Legal clarity is a dded to the current act in its scope, definitions and requirements, including 
those covering risk stemming from new technologies and drive the standardisation activities 
in this area, which enhances safety and ensures a higher level of trust and industry 
competitiveness in the (digital) market. It also adapts the machines presenting high risks to the 
state of the art, removes the internal check option for the conformity assessment of the high -
risk machines, and ensures full coherence with the AI Regulation proposal . It proposes a 
burden reduction measure highly requested by the industry which is allowing digital 
documentation, while at the same time ensuring that end users and consumers can have a 
printed version free of charge if they so request. Finally, t he revised MD will gain in 
coherence and legal certainty by aligning to the NLF and becoming a Regulation. To ensure 
proportionality, this policy option includes the standardisation process with a new 
Standardisation Request issued by the Commission for de tailed technical solutions to be 
developed by the standardisation bodies, and the Machinery Guide for detailed clarification 
and examples.  
As explained in the Impact Assessment, the preferred policy option adheres to the principle of 
proportionality. The proposed changes to the safety requirements are targeted, limited to 
certain machinery types: machinery including new technologies, specific machinery, and 
high-risk machinery. The burden reduction measures are on the contrary aimed at all 
machinery types (such as clarification of substantial modification, digital documentation, 
alignment to the NLF, conversion to a regulation). Proportionality is also ensured by the MD 
being technologically neutral. The proposed clarifications or additions to the safety 
requirements are kept to the strict minimum in the proposal, to be complemented by a new 
Standardisation Request issued by the Commission to empower the standardisation bodies to 
develop voluntary technical solutions.  
2.4. Choice  of the instrument   
The propo sal takes the form of a Regulation. The proposed change from a Directive to a 
Regulation takes into account the Commission’s general objective to simplify the regulatory 
environment and the need to ensure a uniform implementation throughout the Union of th e 
proposed legislation.  
In addition, the machinery directive is a total harmonisation directive, which means that it 
establishes a high level of safety, and does not allow the Member States to impose more 
restrictive obligations. In this respect, a Regula tion by its legal nature, would better ensure 
that Member States do not impose national technical requirements that go beyond the safety 
requirements laid down in Annex I of the current Directive and/or contradict those safety 
requirements.  
The change fro m a Directive to a Regulation will not lead to any change in the regulatory 
approach. The characteristics of the New Approach will be fully preserved, in particular the 
flexibility given to manufacturers in the choice of the means employed to comply with t he EN 6  EN essential requirements (harmonised standards or other technical specifications) and in the 
choice of the procedure  used to demonstrate compliance from among the available conformity 
assessment procedures. The existing mechanisms supporting the implement ation of the 
legislation (standardisation process, working groups, market surveillance, Member States 
administrative cooperation (AdCo), and the development of guidance documents…) will not 
be affected by the nature of the legal instrument and will continu e to operate in the same 
manner under the Regulation as they currently do under the Directive.  
Finally, the use of Regulations in the area of internal market legislation, in accordance also 
with the preference expressed by stakeholders, avoids the risk of  ‘gold plating’. It also allows 
manufacturers to work directly with the Regulation text instead of needing to identify and 
examine 27 transposition laws. On this basis, it is considered that the choice of a Regulation is 
the most appropriate solution for a ll involved parties as it will allow a more rapid and 
coherent application of the proposed legislation and will establish a clearer regulatory 
environment for economic operators.  
3. RESULTS  OF EX-POST  EVALUATIONS,  STAKEHOLDER  
CONSULTATIONS  AND  IMPACT  ASSE SSMENTS  
3.1. Ex-post evaluations/fitness  checks  of existing  legislation  
The evaluation of the directive concluded that a revision should aim to: i) address the risks 
stemming from new technologies while allowing for technical progress; ii) improve the legal 
clarity of some major concepts and definitions in the current text of the MD; iii) simplify the 
requirements for documentation by allowing digital formats, hence reducing administrative 
burden for economic operators, with an additional positive impact on environmental costs; iv) 
ensure coherence with other Directives and Reg ulations for products and improve 
enforcement of the legislation through the alignment to the New Legislative Framework, v) 
reduce costs of transposition by converting the Directive into a Regulation.  
The results of the evaluation have been taken on board  in the proposal.  
3.2. Stakeholder  consultations  
Stakeholders have been consulted throughout the preparation of the revision of the MD, 
including Member States, manufacturers' federations, consumers and workers associations, 
notified bodies and representa tives from standardisation organisations.  
The consultation included meetings for a selected group of experts as well as consultation of 
the machinery Working Group and the machinery AdCo Group of market surveillance 
authorities.  
Some stakeholder’s views h ave evolved following discussions in the machinery Working 
Group and bilateral meetings, in particular on the need to address explicitly the new risks 
stemming from digital emerging technologies.  
 Specific objective 1: Cover new risks related to digital em erging technologies  
While most stakeholders consider that the MD takes innovations sufficiently into account, 
some expressed concerns over the potential impacts of emerging digital technologies on 
safety.  
 Specific objective 2: Ensure coherent interpretatio n of the scope and 
definitions and improve safety for traditional technologies  EN 7  EN On the scope and definitions most stakeholders agreed on adapting the current exclusion of 
low voltage products covered by the Low -Voltage Directive (LVD) in Art. 1.2(k) of the  MD 
to the products integrating Wi -Fi and clarifying the definition of partly completed machinery.   
As for introducing conformity assessment obligations linked to the substantial modification of 
a machinery placed on the market or put into service, the st akeholders’ views diverge. 
Regarding the adaptation of the essential health and safety requirements for traditional 
machinery, most of stakeholders agree to a greater or lesser extent, except for some specific 
cases in which they consider that an adaptatio n is not necessary because other Union 
legislation already covers the risks.  
 Specific objective 3: Reassess machines considered as high risk and reassess 
related conformity procedures  
The question to whether the manufacturer internal checks option in Annex I of the MD leads 
to safety concerns received mixed responses in the public consultation. The interview 
responses, on the other hand often referred to an adaptation and regular update s of the Annex 
I as potential to bring benefits.  
 Specific objective 4: Reduce paper -based requirements for documentation  
On allowing digital formats for documentation, almost all the stakeholder groups representing 
the industry indicated that are in favo ur. Most Member States and consumers organisations 
are in favour of ensuring also paper format.   
 Specific objective 5: Ensure coherence with other product safety legislation  
Alignment to the New Legislative Framework received nearly universal support.  
 Specific objective 6: Avoid divergences in interpretation derived from 
transposition  
Most stakeholders wish to reduce the possible divergences in the interpretation of the 
machinery directive derived from transposition and mention potential benefits of conve rting 
the Directive into a Regulation. For manufacturers, a conversion could lead to a decrease of 
additional costs related to differences in interpretation across Member States.  
3.3. Collection  and use of expertise  - Impact  assessment  
The Commission carr ied out an impact assessment on the revision of the machinery Directive. 
The Regulatory Scrutiny Board (RSB) issued an opinion on the draft impact assessment on 5 
February 2021. The opinion of the Board as well as the final Impact Assessment and its 
execut ive summary are published together with this proposal.  
Based on the information collected, the impact assessment examined and compared four 
options to address problems and issues relating to the Machinery Directive.  
Option 0 Baseline - ‘no change’  
This o ption would leave the standardisation process evolve as usual, without particular focus 
risks stemming from new technologies, and with no particular focus on areas for improvement 
related to traditional technologies. It would also revise the ‘Guide to appl ication of the MD’ 
following the normal process, with limited ambition and no particular push for consensus.  
Option 1 Self -regulation by industry and changes to the Guide  
This option would make no changes to the current act. Clarifications would be introduced in 
the ‘Guide to application of the MD’ with a push for consensus to clarify where possible the EN 8  EN main problems as described in section 1.1. New risks stemming from new technologies (as 
well certain risks from traditional technologies) would be addressed through the issuance of a 
new commission standardisation request to drive the normal standardisation process.  
Option 2 Burden minimisation  
The rationale behind this opt ion is to reduce economic operators’ burden. In view of 
achieving this objective this option aims to increase the legal clarity of some provisions and 
simplify some administrative obligations.  
However, to minimise the economic operators’ burden there woul d be no adaptations in the 
safety requirements for products, thus with no changes in the manufacturers’ obligations for 
designing and manufacturing the machinery. The new risks stemming from new technologies 
(as well certain risks from traditional technolo gies) would be addressed through the issuance 
of a dedicated commission standardisation request to drive the normal standardisation process 
as much as possible.  
Option 3 Burden minimisation and enhanced safety  
This option aims also to increase the legal c larity of some provisions and simplify some 
administrative obligations. In addition, it seeks enhancing safety by adapting the safety 
requirements and tailoring the conformity assessment to the risk related to the machinery 
product, including new technolog ies.    
Option 3 was found to be the preferred option because:  
Option 0 means no action and would not address the problems and issues identified, with the 
risk of not addressing the problems and objectives.  
Option 1 achieves limited results . It does not ensure an effective response to the problems.  
Option 2 boosts competitiveness by minimising burden for manufacturers, without 
diminishing the number of unsafe products in the market.  
On the contrary, option 3 boosts competitiveness by minimising burden fo r manufacturers, 
and additionally enhances safety by clarifying or adding requirements. This comes with 
additional costs for compliance, but also benefits related to less unsafe products in the market. 
This is also the most future -proof option because addr esses the risks from new technologies.  
3.4. Regulatory  fitness  and simplification  
The alignment to the NLF means a better functioning of the directive and its enforcement, but 
also a burden simplification for manufacturers dealing with several product safe ty acts 
applying to their products (e.g. machinery to which both the machinery directive and the radio 
equipment directive apply). It streamlines the process of safeguard procedures, by involving 
manufacturers and Member States before the Commission is not ified and triggers a 
Commission decision only in cases where there is disagreement between Member States.  
Another simplification aspect is the complementarity between the AI and machinery legal 
proposals, where the AI regulation delegates the conformity as sessment to the machinery, so 
that the risk assessment for the whole machinery with AI systems is done only through the 
future regulation on machinery products.  
Finally, the change from a directive to a regulation, will avoid Member States transpositions 
and will ensure coherence in the interpretation of the legal act and in its implementation.    EN 9  EN 4. BUDGETARY  IMPLICATIONS  
This proposal does not have any implications for the Union budget.  
5. OTHER  ELEMENTS  
5.1. Implementation  plans  and monitoring,  evaluatio n and reporting  arrangements  
The Commission will monitor the implementation, the application and the compliance to 
these new provisions with a view to assessing their effectiveness. The regulation will request 
a regular Commission’s evaluation and review a nd the submission of a public report in this 
respect to the European Parliament and to the Council.  
5.2. Detailed  explanation  of the specific  provisions  of the proposal  
Scope and definitions  
The scope of the proposed Regulation remains the same but is clarified by adding the subject 
matter in Article 1, adapting the wording of the scope and adding a new indent in the 
definition of machinery that includes assembly missing only the upload of a s oftware intended 
for its specific application to prevent manufacturers classifying them as partially completed 
machinery. Furthermore, the definition of safety component has been also clarified to include 
non-physical components such as software.  
There is  a new definition of substantial modification to ensure that machinery, placed on the 
market and/or put into service, that suffers substantial modifications is in conformity with the 
essential health and safety requirements in Annex III.  
Additionally, the  general definitions of the NLF Decision 768/2008/EC have been inserted.  
The Regulation clarifies also the application of other specific Union harmonisation legislation 
when the risks to be addressed in the machinery are not contemplated in Annex III.  
Exclusions  
The exemption of the means of transport on road is extended beyond the Union type approval 
legislation to increase the legal certainty. The reason is to prevent that vehicles not covered by 
that legislation are covered by default by the machinery l egislation, as this legislation is not 
meant to regulate risks other than those stemming from the machinery function (such as 
sawing, excavating, etc.), and not the risks exclusively related to its transport function of 
persons or goods. Furthermore, as fo r the exemption on the list of electrical and electronic 
products regulated by the Low Voltage Directive as some of those products are progressively 
incorporating Wi -Fi functions, e.g. washing machines, and are therefore covered by Directive 
2014/53/EU of the European Parliament and of the Council 11as radio equipment, those 
products should also be excluded from the scope of this Regulation.  
High -risk machinery  
The proposal sets up classification rules for high -risk machinery empowering the Commission 
to adopt delegated acts to adapt the list of high -risk machinery in Annex I. This list is obsolete 
                                                 
 
11 Directive 2014/53/EU of the European Parliam ent and of the Council of 16 April 2014 on the 
harmonisation of the laws of the Member States relating to the making available on the market of radio 
equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62).  EN 10  EN and needs to be adapted to the technical progress and new type of machinery presenting high 
risks such as machinery with AI ensuring safety functions.  
Obligatio ns of economic operators  
The proposal incorporates obligations for manufacturers, importers and distributors to be 
aligned with the NLF Decision 768/2008/EC. This will clarify the respective obligations, 
which are proportionate to the economic operators’ responsibilities. Furthermore, when a 
machinery is substantially modified according to the definition, the one that modifies the 
machinery becomes manufacturer and must comply with the relevant obligations. As the 
complexity of the machinery supply chain i s increasing, there is a general obligation of 
cooperation of third parties involved in the machinery supply chain, other than the economic 
operators.  
Presumption of conformity of machinery  
The presumption of conformity of machinery when manufacturers app ly the relevant 
harmonised standards or parts thereof published in the Official Journal of the European Union 
remains. However, in order to ensure the presumption of conformity when there are not 
harmonised standards the Commission will be empowered to ado pt technical specifications. 
This will be a fall -back option to be used only in cases the standardisation bodies are not able 
to provide standards or provide standards that do not respond to the Commission 
standardisation request and the essential health a nd safety requirements of Annex III.  
Conformity assessment  
The proposal keeps the manufacturer internal check option for machinery that is not classified 
as high risk. However, for high -risk machinery, considering that Annex I will be adapted to 
the tech nological progress when needed and the NLF alignment, only third party certification 
will be accepted, even when manufacturers apply the relevant harmonised standards.  
The proposal updates the corresponding modules in line with the NLF Decision 768/2008/EC.  
Notified bodies  
Proper functioning of notified bodies is crucial for ensuring a high level of health and safety 
protection and for the confidence of all interested parties in the New Approach system. 
Therefore, in line with the NLF Decision, the proposal sets out requirements for national 
authorities responsible for conformity assessment bodies (notified bodies). It leaves the 
ultimate responsibility for designating and monitoring notified bodies with the individual 
Member State.  
Union market surveillance, control of machinery entering the union market and union 
safeguard procedure  
The proposal integrates the NLF Decision 768/2008/EC provisions. This will reinforce the 
market surveillance and will clarify the safeguard close procedure. Commission decisions on 
measures taken by Member States on products placed on the EU market will be required only 
if other Member States disagree with such a measure, which will simpli fy Commission’s 
work.  
Essential health and safety requirements (EHSRs) traditional machinery:  
The proposed Regulation adapts or adds following EHSRs to address specific machinery 
risks:  
1.1.2. Principles of safety integration has been adapted to allow t he machinery users to test 
the safety functions of the machinery .  EN 11  EN 1.6.1 on maintenance has been adapted to facilitate a timely and safe rescue when operators 
are trapped in the machine.  
Digital documentation: EHSRs 1.7.4 on instructions and Annex V on th e manufacturer’s 
declaration of conformity allow that manufacturers provide digital instructions and the 
declaration of conformity. Nevertheless, a paper format is mandatory upon request.  
EHSR 1.7.4 on instructions has been further  adapted to request info rmation on emissions of 
hazardous substances from the machinery and EHSRs 2.2.1.1 and 3.6.3.1  on vibrations  
from portable handheld and hand -guided machinery to adapt the instructions on 
vibrations in order to reduce the exposure occupational injury.  
EHSR 2.2 on portable hand -held and/or hand -guided machinery  is adapted to capture or 
reduce emissions of hazardous substances.  
Section 3 on offset risks due to the mobility of machinery has been adapted to address the 
risks on autonomous machines and remote supervisory stations.  
EHSR 3.2.2 seating for mobile machinery has been adapted  to reinforce the drivers’ safety.  
EHSR 3.5.4 on risks of contact with live overhead power lines has been added to avoid the 
accidents when machin ery makes contact with overhead lines.  
EHSR 6.2 on control devices has been adapted allowing when possible on slow -speed lifts 
control devices other than hold -to-run to allow innovation.  
Installation of lifting appliances: in view of facilitating market surveillance activities the 
manufacturer’s declaration of conformity  will add the address where the machine is 
permanently installed only for lifting machinery installed in a building or a structure.  
Essential health and safety requirements machinery with  new digital technologies:  
The risk assessment that manufacturers must carry out before the machinery is placed on the 
market/ put into service will need to include also the risks appearing after the machinery is 
placed on the market due to its evolving a nd autonomous behaviour.  
Cybersecurity with an impact on safety  
In view of addressing, the risks stemming from malicious third party actions and that have an 
impact on the machinery safety the proposal adds a new EHSR 1.1.9  and clarifies E HSR 
1.2.1 on saf ety and reliability of control systems.  
Human -machinery interaction  
Machines are becoming more powerful, autonomous and some look almost like humans, 
which requires adapting the EHSRs related to the contact between the human and the 
machinery i.e. EHSRs 1 .1.6 on ergonomics and 1.3.7  on risks related to moving parts and 
psychological stress.  
Machinery with evolving capacity  
Although AI system risks will be regulated by the Union legislation on AI, the proposal must 
ensure that the entire machinery is safe,  considering the interactions between the machinery 
components including the AI systems. In this respect following EHSRs have been adapted: 
general principles, 1.1.6  on ergonomics, 1.2.1  on safety and reliability of control systems and 
1.3.7  on risks relat ed to moving parts and psychological stress.  
Traceability of machinery safety  
The safety of machinery increasingly relies on the software behaviour once the machinery has 
been placed on the market. In view of supporting the conformity assessment process and the EN 12  EN market surveillance, a few new requirements have been added in EHSR 1.2.1  on safety and 
reliability of control systems and in the information required in the technical file in Annex 
IV.  
Implementing acts  
The proposal empowers the Commission to ad opt, where appropriate, implementing acts to 
ensure the uniform application of this Regulation. Those implementing acts will be adopted in 
accordance with the provisions on implementing acts laid down in Regulation (EU) No 
182/2011 of the European Parliame nt and of the Council of 16 February 2011 laying down the 
rules and general principles concerning mechanisms for control by the Member States of the 
Commission's exercise of implementing powers.  
Delegated acts  
The proposal empowers the Commission to adopt delegated acts in order to adapt the list of 
high risk machinery in Annex I to take into account the progress of technical knowledge or 
new scientific evidence and the indicative list of safety components in An nex II.  
Evaluation and review  
The Commission will monitor the implementation, the application and the compliance to 
these new provisions with a view to assessing their effectiveness. The regulation requests a 
regular Commission’s evaluation and review and the submission of a public rep ort in this 
respect to the European Parliament and to the Council.  
Final provisions  
The proposed Regulation will become applicable 30 months after its entry into force to allow 
manufacturers, notified bodies and Member States time to adapt to the new req uirements. 
However, the safeguard clause procedure needs to be applied shortly after the entry into force 
of this Regulation to simplify the mechanism. Transitional provisions are foreseen for 
products manufactured and the certificates issued by notified b odies under Directive 
2006/42/EC so as to allow stocks to be absorbed and ensure a smooth transition to the new 
requirements. Directive 2006/42/EC will be repealed and replaced by the proposed 
Regulation.  EN 13  EN 2021/0105 (COD)  
Proposal for a  
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
on machinery products  
(Text with EEA relevance)  
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,  
Having regard to the Treaty on t he Functioning of the European Union, and in particular 
Article 114 thereof,  
Having regard to the proposal from the European Commission,  
After transmission of the draft legislative act to the national parliaments,  
Having regard to the opinion of the Europe an Economic and Social Committee1,  
Acting in accordance with the ordinary legislative procedure,  
Whereas:  
(1) Directive 2006/42/EC2 of the European Parliament and of the Council was adopted in 
the context of establishing the internal market, in order to harmonise health and safety 
requirements for machinery in all Member States and to remove obstacles to trade in 
machinery between Member States.  
(2) The machinery sector is an important part of the engineering industry and is one of the 
industrial mainsta ys of the Union economy. The social cost of the large number of 
accidents caused directly by the use of machinery can be reduced by inherently safe 
design and construction of machinery and by proper installation and maintenance.  
(3) Experience with the app lication of Directive 2006/42/EC has shown inadequacies and 
inconsistencies in the product coverage and conformity assessment procedures. It is 
therefore necessary to improve, simplify and adapt the provisions set out in that 
Directive to the needs of the market and provide clear rules in relation to the 
framework within which machinery products may be made available on the market.  
(4) Since the rules setting out the requirements for machinery products, in particular the 
essential health and safety require ments and the conformity assessment procedures, 
need to be of uniform application for all operators across the Union, and not give room 
for divergent implementation by Member States, Directive 2006/42/EC should be 
replaced by a regulation.  
                                                 
 
1 OJ C […], […], p. […].  
2 Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, 
and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).  EN 14  EN (5) Member Stat es are responsible for protecting, on their territory, the health and safety 
of persons, in particular workers and consumers and, where appropriate, domestic 
animals and property, notably in relation to the risks arising out of the use of 
machinery. For th e avoidance of doubt, domestic animals should be considered to 
include farm animals.  
(6) Regulation (EC) No 765/2008 of the European Parliament3 lays down rules on the 
accreditation of conformity assessment bodies, provides a framework for the market 
surveillance of products and for controls on products from third countries, and lays 
down the general principles of the CE marking. That Regulation should be applicable 
to machinery products covered by this Regulation in order to ensure that those 
products, wh ich are benefiting from the free movement of goods within the Union, 
fulfil requirements providing a high level of protection of public interests such as the 
health and safety of persons and, where appropriate, domestic animals and property 
and, where appl icable, the environment.  
(7) Regulation (EC) No 2019/1020 of the European Parliament and of the Council4 sets 
out rules on market surveillance and control of products entering the Union market. 
That Regulation already applies to machinery, since Directive 2006/42/EC is listed in 
its Annex I.   
(8) Decision No 768/2008/EC of the European Parliament and of the  Council5 lays down 
common principles and reference provisions intended to apply across sectoral 
legislation. In order to ensure consistency with other sectoral product legislation, it is 
appropriate to align certain provisions of this Regulation to that D ecision, in so far as 
sectoral specificities do not require a different solution. Therefore, certain definitions, 
the general obligations of economic operators, the rules on presumption of conformity, 
the rules on EU declaration of conformity, the rules on  CE marking, the requirements 
for conformity assessment bodies, the rules on notification procedures and conformity 
assessment procedures and the rules on procedures to deal with machinery products 
presenting a risk should be adapted to the reference provi sions laid down in that 
Decision.  
(9) This Regulation should cover machinery products which are new to the Union market 
when placed on the market, i.e. either new machinery products made by a 
manufacturer established in the Union or machinery products, wh ether new or second -
hand, imported from a third country.  
(10) Where there is a possibility that the machinery products will be used by a consumer, 
that is to say, a non -professional operator, the manufacturer should take account of the 
fact that the consu mer does not have the same knowledge and experience with 
handling machinery products  in the design and construction of the products. The same 
                                                 
 
3 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out  
the requirements for accreditation and market surveillance relating to the marketing of products and 
repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).  
4 Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2 019 on market 
surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 
765/2008 and (EU) No 305/2011 (OJ L169, 25.6.2019, p. 1.)  
5 Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 200 8 on a common 
framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 
13.08.2008, p. 82).  EN 15  EN applies where a machinery product is normally used to provide a service to a 
consumer.  
(11) Recently, more advance d machines, which are less dependent on human operators, 
have been introduced on the market. These machines, known as collaborative robots or 
cobots, are working on defined tasks and in structured environments, yet they can 
learn to perform new actions in this context and become more autonomous. Further 
refinements to machines, already in place or to be expected, include real -time 
processing of information, problem solving, mobility, sensor systems, learning, 
adaptability, and capability of operating in uns tructured environments (e.g. 
construction sites). The Commission Report on the safety and liability implications of 
Artificial Intelligence, the Internet of Things and robotics6, states that the emergence 
of new digital technologies, like artificial intell igence, the Internet of things and 
robotics, raises new challenges in terms of product safety. The report concludes that 
the current product safety legislation, including Directive 2006/42/EC, contains a 
number of gaps in this respect that need to be addre ssed. Thus, this Regulation should 
cover the safety risks stemming from new digital technologies.  
(12) In order to ensure protection of the health and safety of persons, domestic animals, 
property and, where applicable, the environment, this Regulation sho uld apply to all 
forms of supply of machinery products, including distance selling as referred to in 
Article 6 of Regulation (EU) 2019/1020.  
(13) In order to ensure legal certainty for all users, the scope of this Regulation should be 
set out in a clear m anner and the concepts relating to its application should be defined 
as precisely as possible.  
(14) In order to avoid legislating twice the same product, is appropriate to exclude from the 
scope of this Regulation weapons, including firearms that are subje ct to Directive 
(EU) 2017/853  of the European Parliament and of the Council7.  
(15) Since the purpose of this Regulation is to address the risks stemming from the 
machinery function and not the transport of goods or persons, it should not apply to 
vehicles which only objective is the mere transport of goods or persons on road, by air, 
on water or on rail networks, regardless of the speed limits.  However, m achinery 
mounted on such vehicles or mobile machinery intended for facilitating works such as 
in construction sites or warehouses e.g. dumpers and forklifts, have a machinery 
function and should therefore be covered by this Regulation.  Since agricultural and 
forestry vehicles and two - or three -wheel vehicles and quadricycles, as well as 
systems, components, separate technical units, parts and equipment designed and 
constructed for such vehicles, fall within the scope of Regulation (EU) No 167/2013 of 
the E uropean Parliament and of the Council8 and Regulation (EU) No 168/2013 of the 
                                                 
 
6 Report from the Commission to the European parliament, the Council and the European economic  and 
social committee on the safe ty and liability implications of Artificial Intelligence, the Internet of Things 
and robotics (COM/2020/64 final)..   
7 Directive (EU) 2017/853 of the European Parliament and of the Council of 17 May 2017 amending 
Council Directive 91/477/EEC on control of the acquisition and possession of weapons (OJ L 137, 
24.5.2017, p.22).  
8 Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the 
approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2. 3.2013, p. 1).  EN 16  EN European Parliament and of the Council9 respectively, they should be excluded from 
the scope of this Regulation.  
(16) Household appliances intended for domestic use which are no t electrically operated 
furniture, audio and video equipment, information technology equipment, office 
machinery, low -voltage switchgear and control gear and electronic motors fall within 
the scope of Directive 2014/35/EU of the European Parliament and of the Council10 
and should therefore be excluded from the scope of this Regulation. Some of those 
products are progressively incorporating Wi -Fi functions, e.g. washing machines, and 
are therefore covered by Directive 2014/53/EU of the European Parliament and  of the 
Council11as radio equipment. Those products should also be excluded from the scope 
of this Regulation.  
(17) The evolution of the machinery sector has resulted in the growing use of digital means 
and software plays a more and more important role in t he machinery design. 
Consequently, the definition of machinery should be adapted. In this respect, 
machinery missing only the upload of a software intended for the specific application 
of the machinery should fall under the definition of machinery and not under the 
definition of partly completed machinery. Furthermore, the definition of safety 
components should cover not only physical devices but also digital devices. In order to 
take into account the increasing use of software as a safety component, softwa re that 
performs a safety function and is placed independently on the market should be 
considered a safety component.  
(18) Partly completed machinery  is a machinery product which must undergo further 
construction in order to be able to perform its specifi c application, i.e. the well -defined 
operations for which the machinery product is designed. It is not necessary that all 
requirements of this Regulation apply to partly completed machinery but in order to 
ensure the safety of the machinery product as a wh ole, it is nevertheless important that 
the free movement of such partly completed machinery be guaranteed by means of a 
specific procedure.  
(19) Where machinery products pose risks that are addressed by the essential health and 
safety requirements set out  in this Regulation but are also wholly or partly covered by 
other more specific Union legislation, this Regulation should not apply to the extent 
that those risks are covered by that other Union legislation. In other cases, machinery 
products may pose ris ks that are not covered by the essential health and safety 
requirements set out in this Regulation. For example, machinery products 
incorporating a Wi -Fi function or an artificial intelligence system may pose risks not 
addressed by the essential health and  safety requirements set out in this Regulation, as 
this Regulation does not deal with risks specific to such systems. For artificial 
                                                 
 
9 Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the 
approval and market surveillance of two - or three -wheel vehicles and quadricycles (OJ L 60, 2.3.2013, 
p. 52).  
10 Directive 2014/35/EU of the  European Parliament and of the Council of 26 February 2014 on the 
harmonisation of the laws of the Member States relating to the making available on the market of 
electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 35).  
11 Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the 
harmonisation of the laws of the Member States relating to the making available on the market of radio 
equipment and repealing Directive 1999/5/EC (OJ L 153,  22.5.2014, p. 62).  EN 17  EN intelligence systems, the specific Union legislation on artificial intelligence should 
apply, since it contains specific s afety requirements for high -risk artificial intelligence 
systems. In order to avoid incoherence with regard to the type of conformity 
assessment and to avoid introducing requirements to perform two conformity 
assessments, those specific safety requirements  should however be checked as part of 
the conformity assessment procedure set out in this Regulation. The essential health 
and safety requirements set out in this Regulation should in any case be applied in 
order to ensure, where applicable, the safe integ ration of the artificial intelligence 
system into the overall machinery, so as not to compromise the safety of the 
machinery product as a whole.  
(20) For trade fairs, exhibitions and similar events, it should be possible to exhibit 
machinery products whic h do not meet the requirements of this Regulation, since this 
would not pose any safety risk. However, for the sake of transparency, interested 
parties should be properly informed that the machinery products are not compliant and 
cannot be purchased.  
(21) The evolution of the state of the art in the machinery sector has an impact on the 
classification of high -risk machinery products. In view of properly reflecting all high -
risk machinery products, criteria should be established for the assessment by the 
Com mission of which machinery products should be included in the list of high risk 
machinery products.   
(22) Other risks related to new digital technologies are those provoked by malicious third 
parties that have an impact on the safety of machinery products . In this respect, 
manufacturers should be required to adopt proportionate measures which are limited to 
the protection of the safety of the machinery product. This does not preclude the 
application to machinery products of other Union legislation specific ally addressing 
cybersecurity aspects.   
(23) In order to ensure that machinery products, when placed on the market or put into 
service, do not entail health and safety risks for persons or domestic animals and do 
not cause harm to property and, where appl icable, the environment, essential health 
and safety requirements should be set out which have to be met in order for the 
machinery products to be allowed on the market. Machinery products should comply 
with the essential health and safety requirements whe n placed on the market or put 
into service. Where such machinery products are subsequently modified, by physical 
or digital means, in a way that is not foreseen by the manufacturer and that may imply 
that it no longer meets the relevant essential health an d safety requirements, the 
modification should be considered as substantial. For example, users may upload 
software in a machinery product that is not foreseen by the manufacturer and that may 
generate new risks. In order to ensure the compliance of such a  machinery product 
with the relevant essential health and safety requirements, the person that carries out 
the substantial modification should be required to perform a new conformity 
assessment before placing the modified machinery product on the market or  putting it 
into service. That requirement should only apply with respect to the modified part of 
the machinery product, provided that the modification does not affect the machinery 
product as a whole.  In order to avoid an unnecessary and disproportionate  burden, the 
person carrying out the substantial modification should not be required to repeat tests 
and produce new documentation in relation to aspects of the machinery product that 
are not impacted by the modification. It should be up to the person who carries out the 
substantial modification to demonstrate that the modification does not have an impact 
on the machinery product as a whole.  EN 18  EN (24) In the machinery sector, around 98 % of the companies are small or medium sized 
enterprises (SMEs). In order to  reduce the regulatory burden on SMEs, notified bodies 
should adapt the fees for conformity assessments and reduce them proportionately to 
the specific interests and needs of SMEs.  
(25) Economic operators should be responsible for the compliance of machin ery products 
with the requirements of this Regulation, in relation to their respective roles in the 
supply chain, so as to ensure a high level of protection of public interests, such as the 
health and safety of persons, where appropriate, domestic animals and property and, 
where applicable, the environment, as well as the fair competition on the Union 
market.  
(26) All economic operators intervening in the supply and distribution chain should take 
appropriate measures to ensure that they make available on t he market only machinery 
products, which are in conformity with this Regulation. This Regulation should 
provide a clear and proportionate distribution of obligations, which correspond to the 
role of each economic operator in the supply and distribution cha in.  
(27) In order to facilitate communication between economic operators, market surveillance 
authorities and users, Member States should encourage economic operators to include 
a website address in addition to the postal address.  
(28) The manufacturer, having detailed knowledge of the design and production process, is 
best placed to carry out the conformity assessment procedure. Conformity assessment 
should therefore remain solely the obligation of the manufacturer.  
(29) The manufacturer or the manufactu rer’s authorised representative should also ensure 
that a risk assessment is carried out for the machinery product, which the manufacturer 
wishes to place on the market. For this purpose, the manufacturer should determine 
which of the essential health and safety requirements that are applicable to the 
machinery product and in respect of which measures must be taken to address the risks 
that the machinery product may present. Where the machinery product integrates an 
artificial intelligence system, the risks  identified during the risk assessment should 
include those risks that may appear during the machinery product’s lifecycle due to an 
intended evolution of its behaviour to operate with varying levels of autonomy. In this 
respect, where the machinery produc t integrates an artificial intelligence system, the 
risk assessment for the machinery product should consider the risk assessment for that 
artificial intelligence system that has been carried out pursuant to Regulation (EU) 
.../... of the European Parliame nt and of the Council +.  
(30) The safety of the integral machinery product relies on the dependencies and 
interactions between its components and partly completed machinery and individual 
machinery that participate in a coordinated assembly of a machinery system . 
Therefore, manufacturers should be required to assess all those interactions in the risk 
assessment. The risk assessment should also address future updates or developments 
of a software installed in the machinery product, which are foreseen when th e 
machinery product is placed on the market.  
(31) It is essential that, before drawing up the EU declaration of conformity, the 
manufacturer or the manufacturer’s authorised representative established in the Union 
                                                 
 
+  OJ: Please insert in the text the number of the Regulation contained in document … .  EN 19  EN prepares a technical construction file, w hich they should be required to make available 
to national authorities or notified bodies on request. Detailed plans of subassemblies 
used for the manufacture of the machinery product should only be required as part of 
the technical construction file where  knowledge of such plans is essential for  
assessing conformity with the essential health and safety requirements set out in this 
Regulation.  
(32) It is necessary to ensure that machinery products from third countries entering the 
Union market comply with  the requirements of this Regulation and do not pose a risk 
to the health and safety of persons, where appropriate, domestic animals and property 
and, where applicable, the environment, and in particular, that appropriate conformity 
assessment procedures h ave been carried out by manufacturers with regard to such 
machinery products. Provision should therefore be made for importers to ensure that 
machinery products that they place on the market comply with the requirements of this 
Regulation and do not pose a  risk to the health and safety of persons, where 
appropriate, domestic animals and property and, where applicable, the environment. 
For the same reason, provision should also be made for importers to ensure that the 
conformity assessment procedures have be en carried out and that the CE marking and 
technical documentation drawn up by manufacturers are available for inspection by the 
competent national authorities.  
(33) As the distributor makes machinery products available on the market after they have 
been placed on the market by the manufacturer or the importer, the distributor should 
act with due care to ensure that his or her handling of the machinery product does not 
adversely affect its compliance with the requirements set out in this Regulation.  
(34) When placing machinery products on the market, the importer should indicate on the 
machinery product his or her name, registered trade name or registered trade mark and 
the postal address at which he or she can be contacted. Exceptions should be provided 
for in cases where the size or nature of the machinery product does not allow it. This 
includes cases where the importer would have to open the packaging to put his or her 
name and address on the machinery product.  
(35) In view of ensuring the health and s afety of the users of the machinery product, 
economic operators should ensure that all relevant documentation, such as the user's 
instructions, whilst containing precise and comprehensible information, is easily 
understandable, takes into account technolog ical developments and changes to end -
user behaviour, and is as up to date as possible. When machinery products are made 
available on the market in packages containing multiple units, the instructions and 
information should accompany the smallest commercial ly available unit.  
(36) Any economic operator who either places a machinery product on the market under his 
or her own name or trademark or modifies a machinery product in such a way that 
compliance with the requirements of this Regulation may be affected should be 
considered to be the manufacturer and should assume the obligations of the 
manufacturer.  
(37) Distributors and importers, being close to the market place, should be involved in 
market surveillance tasks carried out by the competent national authorities, and should 
be p repared to participate actively, providing those authorities with all necessary 
information relating to the machinery product concerned.  
(38) Ensuring traceability of machinery products throughout the whole supply chain 
enables a simpler and more efficien t market surveillance. The economic operators EN 20  EN should therefore be required to keep the information on their transactions of machinery 
products for a certain period of time. However, that obligation should be proportionate 
to the role of each economic opera tor in the supply chain and the economic operators 
should not be required to update information that they have not produced.  
(39) This Regulation should be limited to setting out the essential health and safety 
requirements, supplemented by a number of mo re specific requirements for certain 
categories of machinery products. In order to facilitate the assessment of conformity 
with those health and safety requirements it is necessary to provide for a presumption 
of conformity for machinery which is in confor mity with harmonised standards that 
are developed and which references are published in the Official Journal of the 
European Union in accordance with Regulation (EU) No 1025/2012 of the European 
Parliament and of the Council12 for the purpose of expressing detailed technical 
specifications of those requirements.  
(40) In the absence of relevant harmonised standards, the Commission should be able to 
establish technical specifications for the essential health and safety requirements. 
Recourse to technical spec ifications should be used as a fall back solution to facilitate 
the manufacturer’s obligation to comply with the health and safety requirements, for 
instance when the standardisation process is blocked due to a lack of consensus 
between stakeholders or the re are undue delays in the establishment of a harmonised 
standard. Such delays could for example occur when the required quality is not 
reached.  
(41) Compliance with harmonised standards and with technical specifications established 
by the Commission shou ld be voluntary. Alternative technical solutions should 
therefore be acceptable where compliance of the machinery with the relevant essential 
health and safety requirements is demonstrated in the technical file.  
(42) The essential health and safety requir ements should be satisfied in order to ensure that 
the machinery product is safe. Those requirements should be applied with discernment 
to take account of the state of the art at the time of construction and of technical and 
economic requirements.  
(43) In view of addressing the risks stemming from malicious third party actions that have 
an impact on the safety of machinery products, this Regulation should include 
essential health and safety requirements for which a presumption of conformity may 
be given to the appropriate extent by a certificate or statement of conformity issued 
under a relevant cybersecurity scheme adopted pursuant to and in accordance with 
Article 54(3) of Regulation (EU) 2019/881 of the European Parliament and of the 
Council13.   
                                                 
 
12 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on 
European standardisation, amending Council Direc tives 89/686/EEC and 93/15/EEC and Directives 
94/9/EC, 94/25/EC(52), 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 
2009/105/EC of the European Parliament and of the Council and repealing Council Decision 
87/95/EEC and Decision No 167 3/2006/EC of the European Parliament and of the Council (OJ L 316, 
14.11.2012, p. 12).  
13 Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA 
(the European Union Agency for Cybersecurity) and on information and communications technology 
cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 
7.6.2019, p. 15).  EN 21  EN (44) Regu lation (EU) No 1025/2012 provides for a procedure for objections to harmonised 
standards where those standards do not satisfy or entirely satisfy the requirements of 
this Regulation.  
(45) The list of high -risk machinery in Annex I to Directive 2006/42/EC is so far based on 
the risk emanating from the intended use or any reasonably foreseeable misuse of that 
machinery. Nevertheless, the machinery sector embraces new ways of designing and 
constructing machinery products that may imply high risks, regardless of such 
intended use or any reasonably foreseeable misuse. For example, software ensuring 
safety functions of machinery based on artificial intelligence, embedded or not in the 
machinery product, should be classified as a high -risk machinery product due to  the 
characteristics of artificial intelligence such as data dependency, opacity, autonomy 
and connectivity, which might increase very much the probability and severity of harm 
and seriously affect the safety of the machinery product. Furthermore, the mark et for 
software ensuring safety functions of machinery products based on artificial 
intelligence is so far very small, which results in a lack of experience and data. 
Therefore, the conformity assessment of software ensuring safety functions based on 
artificial intelligence should be carried out by a third party.   
(46) Manufacturers should draw up an EU declaration of conformity to provide information 
on the conformity of machinery products with this Regulation. Manufacturers may 
also be required to draw u p an EU declaration of conformity by other Union 
legislation. To ensure effective access to information for market surveillance purposes, 
a single EU declaration of conformity should be drawn up in respect of all Union acts. 
In order to reduce the administ rative burden on economic operators, it should be 
possible for that single EU declaration of conformity to be a dossier made up of 
relevant individual declarations of conformity.  
(47) The CE marking, indicating the conformity of a product, is the visible consequence of 
a whole process comprising conformity assessment in a broad sense. The general 
principles governing the CE marking are set out in Regulation (EC) No 765/2008. 
Rules governing the affixing of the CE marking on machinery products should be lai d 
down in this Regulation.  
(48) The CE marking should be the only marking, which guarantees that machinery 
products comply with the requirements of this Regulation. Member States should 
therefore take appropriate action as regards other markings which are  likely to mislead 
third parties as to the meaning or the form of the CE marking.  
(49) In order to enable economic operators to demonstrate and the competent authorities to 
ensure that machinery made available on the market is in conformity with the essent ial 
health and safety requirements, it is necessary to provide for conformity assessment 
procedures. Decision No 768/2008/EC establishes modules for conformity assessment 
procedures, which include procedures from the least to the most stringent, in 
proport ion to the level of risk involved and the level of safety required. In order to 
ensure inter -sectoral coherence and to avoid ad -hoc variants, conformity assessment 
procedures should be chosen from among those modules.  
(50) Manufacturers should be responsi ble for certifying the conformity of their machinery 
products with this Regulation. Nevertheless, for certain types of machinery products 
that have a higher risk factor, a stricter certification procedure requiring participation 
of a notified body should b e required.  EN 22  EN (51) It is essential that all notified bodies perform their functions to the same level and 
under conditions of fair competition. That requires the setting of obligatory 
requirements for conformity assessment bodies wishing to be notified in o rder to 
provide conformity assessment services.  
(52) If a conformity assessment body demonstrates conformity with the criteria laid down 
in harmonised standards, it should be presumed to comply with the corresponding 
requirements set out in this Regulation.  
(53) In order to ensure a consistent level of qual ity in the performance of conformity 
assessment of machinery products, it is also necessary to set requirements for 
notifying authorities and other bodies involved in the assessment, notification and 
monitoring of notified bodies.  
(54) The system set out in this Regulation should be complemented by the accreditation 
system provided for in Regulation (EC) No 765/2008. Since accreditation is an 
essential means of verifying the competence of conformity assessment bodies, it 
should also be used for the purpose s of notification.  
(55) Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring 
the necessary level of confidence in certificates of conformity, should be considered 
by the national public authorities throughout the Union as the  preferred means of 
demonstrating the technical competence of conformity assessment bodies. However, 
national authorities may consider that they possess the appropriate means of carrying 
out that evaluation themselves. In such cases, in order to ensure the  appropriate level 
of credibility of evaluations carried out by other national authorities, they should 
provide the Commission and the other Member States with the necessary documentary 
evidence demonstrating the compliance of the conformity assessment bod ies evaluated 
with the relevant regulatory requirements.  
(56) Conformity assessment bodies frequently subcontract parts of their activities linked to 
the assessment of conformity or have recourse to a subsidiary. In order to safeguard 
the level of protect ion required for the machinery to be placed on the market, it is 
essential that conformity assessment subcontractors and subsidiaries fulfil the same 
requirements as notified bodies in relation to the performance of conformity 
assessment tasks. Therefore, it is important that the assessment of the competence and 
the performance of bodies to be notified, and the monitoring of bodies already 
notified, cover also activities carried out by subcontractors and subsidiaries.  
(57) Since notified bodies may offer t heir services throughout the Union, it is appropriate to 
give the other Member States and the Commission the opportunity to raise objections 
concerning a notified body. It is therefore important to provide for a period during 
which any doubts or concerns a s to the competence of conformity assessment bodies 
can be clarified before they start operating as notified bodies.  
(58) In the interests of competitiveness, it is crucial that notified bodies apply the 
conformity assessment procedures without creating u nnecessary burdens for economic 
operators. For the same reason, and to ensure equal treatment of economic operators, 
consistency in the technical application of the conformity assessment procedures needs 
to be ensured. That can best be achieved through app ropriate coordination and 
cooperation between notified bodies.  
(59) Market surveillance is an essential instrument inasmuch as it ensures the proper and 
uniform application of Union legislation. It is therefore appropriate to put in place a EN 23  EN legal framewor k within which market surveillance can be carried out in an appropriate 
manner.  
(60) Member States should take all appropriate measures to ensure that machinery products 
covered by this Regulation may be placed on the market only if, when properly 
installe d and used for its intended purpose, or under conditions of use which can be 
reasonably foreseen, it does not endanger the health or safety of persons, and, where 
appropriate, domestic animals and property and, where applicable, the environment. 
Machinery products covered by this Regulation should be considered as non -
compliant with the essential health and safety requirements laid down in this 
Regulation only under conditions of use, which could result from lawful and readily 
predictable human behaviour.  
(61) In the context of market surveillance, a clear distinction should be established between 
the disputing of a harmonised standard conferring a presumption of conformity on 
machinery products and the safeguard clause relating to machinery products.  
(62) Directive 2006/42/EC already provides for a safeguard procedure, which is necessary 
to allow for the possibility of contesting the conformity of machinery products. In 
order to increase transparency and to reduce processing time, it is necessary to 
improve  the existing safeguard procedure, with a view to making it more efficient and 
drawing on the expertise available in Member States.  
(63) The existing safeguard procedure should be supplemented by a procedure under which 
interested parties are informed of measures intended to be taken with regard to 
machinery products posing  a risk to the health or safety of persons and, where 
appropriate, domestic animals and property and, where applicable, the environment. It 
should allow market surveillance authorities,  in cooperation with the relevant 
economic operators, to act at an earlier stage in respect of such machinery products.  
(64) Where the Member States and the Commission agree as to the justification of a 
measure taken by a Member State, no further involveme nt of the Commission should 
be required, except where non -compliance can be attributed to shortcomings of a 
harmonised standard.  
(65) In order to take into account technical progress and knowledge or new scientific 
evidence, the power to adopt acts in accordance with Article 290 of the Treaty on the 
Functioning of the European Union should be delegated to the Commission in respect 
of ame nding the list of high -risk machinery products and the indicative list of safety 
components. It is of particular importance that the Commission carries out appropriate 
consultations during its preparatory work, including at expert level. The Commission, 
when preparing and drawing up delegated acts, should ensure a simultaneous, timely 
and appropriate transmission of relevant documents to the European Parliament and to 
the Council.  
(66) In order to ensure uniform conditions for the implementation of this Re gulation, 
implementing powers should be conferred on the Commission establishing technical 
specifications for the essential health and safety requirements, requesting the notifying 
Member State to take the necessary corrective measures in respect of a noti fied body 
that does not meet the requirements for its notification and establishing whether a 
national measure in respect of compliant machinery which a Member State finds to  EN 24  EN pose a risk to health and safety of persons is justified. Those powers should be  
exercised in accordance with Regulation (EU) No 182/2011 of the European 
Parliament and of the Council14. 
(67) The Commission should adopt immediately applicable implementing acts determining 
whether a national measure taken in respect of compliant machine ry products that 
poses a risk is justified or not where, in duly justified cases relating to the protection of 
the health or safety of persons, imperative grounds of urgency so require.  
(68) In line with established practice, the committee set up by this Regulation can play a 
useful role in examining matters concerning the application of this Regulation raised 
either by its chair or by a representative of a Member State in accordance with its rules 
of procedure.  
(69) When matters relating to this Regulati on, other than its implementation or 
infringements, are being examined in a Commission expert group, the European 
Parliament should in line with existing practice receive full information and 
documentation and, where appropriate, an invitation to attend su ch meetings.  
(70) The Commission should, by means of implementing acts and, given their special 
nature, acting without the application of Regulation (EU) No 182/2011, determine 
whether measures taken by Member States in respect of non -compliant machinery 
products are justified or not.  
(71) The traceability of machinery data required for the technical file and for market 
surveillance purposes, must comply with confidentiality rules to protect 
manufacturers.  
(72) Member States should lay down rules on pena lties applicable to infringements of this 
Regulation and ensure that those rules are enforced. The penalties provided for should 
be effective, proportionate and dissuasive.  
(73) Since the objective of this Regulation, namely to ensure that machinery produ cts 
placed on the market fulfils the requirements providing for a high level of protection 
of health and safety of persons, and, where appropriate, domestic animals and property 
and, where applicable, the environment, while guaranteeing the functioning of the 
internal market, cannot be sufficiently achieved by the Member States, but can rather, 
by reason of the need for harmonisation , be better achieved at Union level, the Union 
may adopt measures, in accordance with the principle of subsidiarity set out i n Article 
5 of the Treaty on European Union. In accordance with the principle of 
proportionality, as set out in that Article, this Regulation does not go beyond what is 
necessary in order to achieve that objective.  
(74) Council Directive 73/361/EEC15 on th e approximation of the laws, regulations and 
administrative provisions of the Member States relating to the certification and 
                                                 
 
14 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 
laying down the  rules and general principles concerning mechanisms for control by Member States of 
the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).  
15 Council Directive 73/361/EEC of 19 November 1973 on the approximation of the laws, regulati ons and 
administrative provisions of the Member States relating to the certification and marking of wire -ropes, 
chains and hooks ( OJ L 335, 5.12.1973, p. 51 –55).  EN 25  EN marking of wire -ropes, chains and hooks should be repealed as Directive 2006/42/EC 
took over its scope by including lifting access ories  and chains and ropes.  
(75) Directive 2006/42/EC has been amended several times. Since further substantial 
amendments are needed, and in order to ensure a uniform implementation of the rules 
on machinery products throughout the Union, Directive 2006/ 42/EC should be 
repealed.  
(76) It is necessary to provide for sufficient time for economic operators to comply with 
their obligations under this Regulation, and for Member States to set up the 
administrative infrastructure necessary for its application. T he application of this 
Regulation should therefore be deferred,  
HAVE ADOPTED THIS REGULATION:  
CHAPTER I  
GENERAL PROVISIONS  
Article 1  
Subject matter  
This Regulation lays down requirements for the design and construction of machinery 
products to allow the making available on the market or putting into service of machinery 
products, and establishes rules on the free movement of machinery products in the Union.  
Article 2  
Scope  
(1) This Regulation applies to the following machinery products  
(a) machinery;  
(b) interchangeable equipment;  
(c) safety components;  
(d) lifting accessories;  
(e) chains, ropes, slings and webbing;  
(f) removable mechanical transmi ssion devices;  
(g) partly completed machinery.  
(2) This Regulation does not apply to:  
(a) safety components that are intended to be used as spare parts to replace 
identical components and are supplied by the manufacturer of the original 
machinery product;  
(b) specific equipment for use in fairgrounds or amusement parks;  
(c) machinery specially designed or put into service for nuclear purposes which, in 
the event of failure, may result in an emission of radioactivity;  
(d) weapons, including firearms ;  EN 26  EN (e) vehicles which have as their only objective the transport of goods or persons by 
road, air, water or rail except for machinery mounted on those vehicles;  
(f) two- or three -wheel vehicles and quadricycles, as well as systems, components, 
separate tec hnical units, parts and equipment designed and constructed for such 
vehicles, that fall within the scope of application of Regulation (EU) No 
168/2013;  
(g) agricultural and forestry vehicles, as well as systems, components, separate 
technical units, parts and equipment designed and constructed for such 
vehicles, that fall within the scope of application of Regulation (EU) No 
167/2013;  
(h) seagoing vessels and mobile offshore units and machinery installed on board 
such vessels or units;  
(i) machinery special ly designed and constructed for military or police purposes;  
(j) machinery specially designed and constructed for research purposes for 
temporary use in laboratories;  
(k) mine winding gear;  
(l) machinery intended to move performers during artistic performa nces;  
(m) the following electrical and electronic products,  insofar as they fall within the 
scope of application of Directive 2014/35/EU or Directive 2014/53/EU :  
(i) household appliances intended for domestic use which are not 
electrically operated furni ture;  
(ii) audio and video equipment;  
(iii) information technology equipment;  
(iv) office machinery;  
(v) low-voltage switchgear and control gear;  
(vi) electric motors;  
(n) the following high -voltage electrical products:  
(i) switch gear and control gear;  
(ii) transformers.  
Article 3  
Definitions  
For the purposes of this Regulation, the following definitions shall apply:  
(1) ‘machinery’ means:  
(a) an assembly, fitted with or intended to be fitted with a drive system other than 
directly applied human or anima l effort, consisting of linked parts or 
components, at least one of which moves, and which are joined together for a 
specific application;  
(b) an assembly referred to in point (a), missing only the components to connect it 
on site or to sources of energy and motion;  EN 27  EN (c) an assembly referred to points (a) and (b), ready to be installed and able to 
function as it stands only if mounted on a means of transport, or installed in a 
building or a structure;  
(d) assemblies of machinery referred to in points (a), ( b), (c) or partly completed 
machinery referred to in point (7) which, in order to achieve the same end, are 
arranged and controlled so that they function as an integral whole;  
(e) an assembly of linked parts or components, at least one of which moves and 
which are joined together, intended for lifting loads and whose only power 
source is directly applied human effort;  
(f) an assembly as referred to in points (a), (b), (c), (d) and (e) missing only the 
upload of a software intended for its specific applicati on.  
(2) ‘interchangeable equipment’ means a device which, after the putting into service of a 
machinery product, is assembled with that machinery product by the operator himself 
in order to change its function or attribute to it a new function, in so far as that 
equipment is not a tool;  
(3) ‘safety component’ means a physical or digital component, including software, of 
machinery which serves to fulfil a safety function and which is independently placed 
on the market, the failure or malfunction of which en dangers the safety of persons 
but which is not necessary in order for the machinery to function or may be 
substituted by normal components in order for the machinery to function;  
(4) ‘lifting accessory’ means a component or equipment not attached to the li fting 
machinery, allowing the load to be held, which is placed between the machinery and 
the load or on the load itself, or which is intended to constitute an integral part of the 
load and which is independently placed on the market, including slings and t heir 
components;  
(5) ‘chains’ means chains designed and constructed for lifting purposes as part of lifting 
machinery or lifting accessories;  
(6) ‘ropes’ means ropes designed and constructed for lifting purposes as part of lifting 
machinery or lifting acc essories;  
(7) ‘slings’ means slings designed and constructed for lifting purposes as part of lifting 
machinery or lifting accessories;  
(8) ‘webbing’ means webbing designed and constructed for lifting purposes as part of 
lifting machinery or lifting acces sories;  
(9) ‘removable mechanical transmission device’ means a removable component for 
transmitting power between self -propelled machinery or a tractor and another 
machine by joining them at the first fixed bearing;  
(10) ‘partly completed machinery’ mean s an assembly which is machinery but for the fact  
that it cannot in itself function so as to perform a specific application and which is 
only intended to be incorporated into or assembled with machinery or other partly 
completed machinery or equipment, th ereby forming a machinery product;  
(11) ‘making available on the market’ means any supply of a machinery product for 
distribution or use on the Union market in the course of a commercial activity, 
whether in return for payment or free of charge;  EN 28  EN (12) ‘placing on the market’ means the first making available of a machinery product on 
the Union market;  
(13) ‘putting into service’ means the first use, for its intended purpose, in the Union, of a 
machinery product;  
(14) ‘Union harmonisation legislation’ means any Union legislation harmonising the 
conditions for the marketing of products;  
(15) ‘artificial intelligence system’ means an artificial intelligence system as defined in 
Article 3(1) of Regulation (EU) .../... of the European Parliament and of the Counc il+  
(16) ‘substantial modification’ means a modification of a machinery product, by physical 
or digital means after that machinery product has been placed on the market or put 
into service, which is not foreseen by the manufacturer and as a result of whic h the 
compliance of the machinery product with the relevant essential health and safety 
requirements may be affected;  
(17) ‘manufacturer’ means any natural or legal person who manufactures machinery 
products or who has machinery products designed or manufactured, and markets 
those machinery products under his or her name or trademark or who designs and 
constructs machinery pro ducts for his or her own use;  
(18) ‘instructions for use’ means the information provided by the manufacturer when the 
machinery product is placed on the market or put into service to inform the user of 
the machinery product of the intended purpose and the  proper use of that machinery 
product as well as information on any precautions to be taken when using or 
installing the machinery product, including information on the safety aspects;  
(19) ‘authorised representative’ means any natural or legal person esta blished within the 
Union who has received a written mandate from a manufacturer to act on his or her 
behalf in relation to specified tasks;  
(20) ‘importer’ means any natural or legal person established within the Union who 
places machinery products from a  third country on the Union market;  
(21) ‘distributor’ means any natural or legal person in the supply chain, other than the 
manufacturer or the importer, who makes machinery products available on the 
market;  
(22) ‘economic operators’ means the manufactur er, the authorised representative, the 
importer and the distributor;  
(23) ‘technical specification’ means a document that prescribes technical requirements to 
be fulfilled by machinery products;  
(24) ‘harmonised standard’ means a harmonised standard as d efined in Article  2(1), point 
(c) of Regulation  (EU) No  1025/2012;  
(25) ‘CE marking’ means a marking by which the manufacturer indicates that a 
machinery product is in conformity with the applicable requirements set out in Union 
harmonisation legislation p roviding for its affixing;  
                                                 
 
+  OJ: Please insert in the text the number of the Regulation contained in document … and insert the 
number, date, title and OJ reference of that Regulation in the footnote."  EN 29  EN (26) ‘accreditation’ means accreditation as defined in Article 2, point (10) of Regulation 
(EC) No 765/2008;  
(27) ‘national accreditation body’ means a national accreditation body as defined in 
Article 2(11) of Regulation (EC) No 765/2008;  
(28) ‘conformity assessment’ means the process demonstrating whether the essential 
health and safety requirements of this Regulat ion relating to machinery products 
have been fulfilled;  
(29) ‘conformity assessment body’ means a body that performs conformity assessment 
activities, including calibration, testing, certification and inspection;  
(30) ‘notified body’ means a conformity a ssessment body notified in accordance with 
Article 26 of this Regulation;  
(31) ‘market surveillance authority’ means a market surveillance authority as defined in 
Article 3, point (4) of Regulation (EU) 2019/1020;  
(32) ‘recall’ means any measure aimed at  achieving the return of a machinery product that 
has already been made available to the end -user;  
(33) ‘withdrawal’ means any measure aimed at preventing a machinery product in the 
supply chain from being made available on the market.  
Article 4   
Free m ovement  
1. Member States shall not impede, for reasons relating to the aspects covered by this 
Regulation, the making available on the market or the putting into service of 
machinery products which comply with this Regulation.  
2. At trade fairs, exhibiti ons and demonstrations or similar events, Member States shall 
not prevent the display of a machinery product which does not comply with this 
Regulation, provided that a visible sign clearly indicates that it does not comply with 
this Regulation and will no t be available on the market until it has been brought into 
conformity.  
During demonstrations, adequate measures shall be taken to ensure the protection of 
persons.  
Article 5  
High -risk machinery products  
1. High -risk machinery products listed in Annex I shall be subject to a specific 
conformity assessment procedure, as referred to in Article 21(2).  
2. The Commission is empowered to adopt delegated acts in accordance with Article 45 
to amend Annex I in view of technical progress and knowledge or new sci entific 
evidence by including in the list of high -risk machinery products a new machinery 
product or withdrawing an existing machinery product from that list, pursuant to the 
criteria laid down in paragraphs 3 and 4.  
3. A machinery product shall be includ ed in the list of high -risk machinery products in 
Annex I if it poses a risk to human health taking into account its design and intended EN 30  EN purpose. A machinery product shall be withdrawn from the list of high -risk 
machinery products in Annex I if it no longe r poses such risk. The risk posed by a 
certain machinery product shall be established based on the combination of the 
probability of occurrence of harm and the severity of that harm.  
In determining the probability and severity of harm, the following shall  be taken into 
account:  
(a) the degree to which each affected person would be impacted by the harm;  
(b) the number of persons potentially affected;  
(c) the degree to which potentially affected parties are dependent on the 
outcome produced by the machinery  product;  
(d) the degree to which potentially affected parties are in a vulnerable 
position vis -à-vis the user of the machinery product;  
(e) the degree of reversibility of the harm produced by the machinery 
product;  
(f) the degree to which the machinery product has been used for a specific 
purpose;  
(g) indications of harm that have been caused in the past by machinery 
products which have been used for a specific purpose.  
4. The Commission shall thoroughly assess the criteria laid down in paragraph 3 on th e 
basis of available information. In particular the following information shall be 
communicated to the Commission by the Member States when it becomes available 
to them in connection with market surveillance or as a result of the concerns referred 
to in th e fifth paragraph:  
(a) an assessment of the risks as referred to in paragraph 3;  
(b) a cost -effectiveness analysis;  
(c) a machinery accident analysis;  
(d) statistics on accidents caused by the machinery product for the preceding 
four years based, in particular information obtained from the Information 
and Communication System for Market Surveillance (ICSMS) 
information, safeguard clauses, Rapid Alert System (RAPEX)  and the 
Machinery Administrative Cooperation Group reporting.  
5. A Member State which has concerns about a machinery product being listed or not 
listed in Annex I shall immediately inform the Commission of its concerns and 
provide reasons in support thereof.  
Article 6  
Safety components  
1. An indicative list of safety components is set out in Annex II.  
2. The Commission is empowered to adopt delegated acts in accordance with Article 45 
to amend Annex II in view of technical progress and knowledge or new scientific 
evidence by including a new safety component in the indicative list of safety 
components or withdrawing an existing safety component from that list.  EN 31  EN 3. The Commission shall thoroughly assess the risks that require the inclusion of a new 
safety component in the list of safety components in Annex II or a withdrawal of a 
safety compon ent from that list.  
4. A Member State which has concerns about a safety component being listed or not 
listed in Annex II shall immediately inform the Commission of its concerns and 
provide reasons in support thereof.  
Article 7  
Requirements for machinery  products  
Machinery products shall only be made available on the market or put into service if, where 
properly installed and maintained and used for their intended purpose or under conditions 
which can reasonably be foreseen, they meet the essential health  and safety requirements set 
out in Annex III.  
Article 8  
Specific Union harmonisation legislation  
Where, for a certain machinery product, the risks addressed by the essential health and safety 
requirements set out in Annex III are wholly or partly covere d by other more specific Union 
harmonisation legislation, this Regulation shall not apply  to that machinery  product to the 
extent that that specific Union legislation covers  such risks.  
Article 9  
Regulation (EU) .../... of the European Parliament and of the Council+  
Where machinery products contain an artificial intelligence system, to which the essential 
health and safety requirements of Regulation (EU) …/… apply, this Regulation shall, in 
relation to that artificial intelligence system, only apply with regard to its safe integration into 
the overall machinery, so as not to compromise the safety of the machinery product as a 
whole.  
                                                 
 
+  OJ: Please insert in the text the number of the Regulation contained in document … .  EN 32  EN CHAPTER II  
OBLIGATIONS OF ECONOMIC OPERATORS  
Article 10  
Obligations of manufacturers  
1. When placing a machinery product on the market, manufacturers shall ensure that it 
has been designed and constructed in accordance with the essential health and safety 
requirements set out in Annex  III. 
2. Before placing a machinery product on the market, manufacturers shall draw up the 
technical documentation referred to in Annex IV (‘technical documentation’) and 
carry out the relevant conformity assessment procedures referred to in Article  21 or 
Article 22 or have them carried out.  
Where compliance of the machinery product with the esse ntial health and safety 
requirements laid down in Annex III has been demonstrated by that conformity 
assessment procedure, manufacturers shall draw up the EU declaration of conformity 
in accordance with Article  18 and affix the CE marking in accordance wit h 
Article  20, except for partially completed machinery.  
3. Manufacturers shall keep the technical documentation and the EU declaration of 
conformity, where relevant, at the disposal of the market surveillance authorities for 
ten years after the machinery product has been placed on the market. Where relevant, 
the source code or programmed logic included in the technical documentation shall 
be made available upon a reasoned request from the competent national authorities 
provided that it is necessary in orde r for those authorities to be able to check 
compliance with the essential health and safety requirements set out in Annex III.  
4. Manufacturers shall ensure that procedures are in place for machinery products that 
are part of a series production to remain  in conformity with this Regulation. Changes 
in the production process or in  the design or characteristics of the machinery product 
and changes in the harmonised standards or the technical specifications referred to in 
Article 17 by reference to which the conformity of the machinery product is declared 
or by application of which its conformity is verified shall be adequately taken into 
account.  
When deemed appropriate with regard to the risks presented by machinery products, 
manufacturers  shall, to protect the health and safety of end -users , carry out sample 
testing of machinery products made available on the market or put into service, 
investigate, and, if necessary, keep a register of complaints, of non -conforming 
machinery products and machinery product r ecalls, and shall keep distributors 
informed of any such monitoring.  
5. Manufacturers shall ensure that the machinery products which they place on the 
market bears a type, batch or serial number or other element allowing its 
identification, or, where the s ize or nature of the machinery product does not allow it, 
that the required information is provided on the packaging or in a document 
accompanying the machinery product.  
6. Manufacturers shall indicate their name, registered trade name or registered trade  
mark, the postal address and the email address at which they can be contacted on the EN 33  EN machinery product or, where that is not possible, on its packaging or in a document 
accompanying the machinery product. The address shall indicate a single point at 
which  the manufacturer can be contacted. The contact details shall be in a language 
easily understood by end -users and market surveillance authorities.  
7. Manufacturers shall ensure that the machinery products are accompanied by the 
instructions and information  set out in section  1.7 of Annex  III in a language which 
can be easily understood by end -users, as determined by the Member State 
concerned. Such instructions and information shall be clear, understandable, 
intelligible and legible.  
8. Manufacturers shall either provide the EU declaration of conformity with the 
machinery product or include in the instructions and information set out in section 
1.7 of Annex III the internet address at which the EU declaration of conformity can 
be accessed.  
9. Manufacturers w ho consider or have reason to believe that a machinery product, 
which they have placed on the market or put into service is not in conformity with 
the essential health and safety requirements set out in Annex III shall immediately 
take the corrective measu res necessary to bring that machinery product into 
conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the 
machinery product presents a risk, manufacturers shall immediately inform the 
competent national authorities of the Member  States in which they made the 
machinery product available on the market to that effect, giving details, in particular, 
of the non -conformity and of any corrective measures taken.  
10. Manufacturers shall, further to a reasoned request from a competent nati onal 
authority, provide it with all the information and documentation, in paper or 
electronic form, necessary to demonstrate the conformity of the machinery product 
with the essential health and safety requirements set out in Annex III, in a language 
which  can be easily understood by that authority. They shall cooperate with that 
authority, at its request, on any measures taken to eliminate the risks posed by the 
machinery product, which they have placed on the market or put into service.  
Article 11  
Authorised representatives  
1. A manufacturer may, by a written mandate, appoint an authorised representative.  
The obligations laid down in Article  10(1) and the obligation to draw up the 
technical documentation  shall not form part of the authorised represe ntative's 
mandate.  
2. An authorised representative shall perform the tasks specified in the mandate 
received from the manufacturer. The mandate shall allow the authorised 
representative to do at least the following:  
(a) keep the EU declaration of conformit y and the technical documentation at the 
disposal of the national market surveillance authorities for ten years after the 
machinery product has been placed on the market;  
(b) further to a reasoned request from a competent national authority, provide that 
authority with all the information and documentation necessary to demonstrate 
the conformity of the machinery product;  EN 34  EN (c) cooperate with the competent national authorities, at their request, on any 
measures taken to eliminate the risks posed by a machinery  product covered by 
the authorised representative's mandate.  
Article 12  
Obligations of importers  
1. Importers shall only place on the market machinery products that comply with the 
essential health and safety requirements set out in Annex III.  
2. Before pl acing a machinery product on the market, importers shall ensure that the 
appropriate conformity assessment procedures referred to in Article  21 or Article 22 
have been carried out by the manufacturer. They shall ensure that the manufacturer 
has drawn up th e technical documentation, that the machinery product bears the CE 
marking referred to in Article 19 and is accompanied by the required documents, and 
that the manufacturer has complied with the requirements set out in Article  10(5) 
and (6). 
Where an impor ter considers or has reason to believe that a machinery product is not 
in conformity with the essential health and safety requirements set out in Annex III, 
the importer shall not place it on the market until it has been brought into conformity. 
Furthermor e, where the machinery product poses a risk to the health and safety of 
persons and, where appropriate, domestic animals and property and, where 
applicable, the environment, the importer shall inform the manufacturer and the 
market surveillance authorities  to that effect.  
3. Importers shall indicate their name, registered trade name or registered trade mark, 
the postal address and the email address at which they can be contacted on the 
machinery product or, where that is not possible, on its packaging or in  a document 
accompanying the machinery product. The contact details shall be in a language 
easily understood by end -users and market surveillance authorities.  
4. Importers shall ensure that the machinery product is accompanied by the instructions 
and infor mation set out in section  1.7 of Annex  III in a language which can be easily 
understood by end -users, as determined by the Member State concerned.  
5. Importers shall ensure that, while the machinery product is under their responsibility, 
storage or transpo rt conditions do not jeopardise its conformity with the essential 
health and safety requirements set out in Annex  III. 
6. When deemed appropriate with regard to the risks to the health and safety of persons 
and, where appropriate, domestic animals and prop erty and, where applicable, the 
environment, presented by a machinery product, importers shall carry out sample 
testing of machinery products made available on the market, investigate, and, if 
necessary, keep a register of complaints, of non -conforming mac hinery products and 
machinery products recalls, and shall keep distributors informed of any such 
monitoring.  
7. Importers who consider or have reason to believe that a machinery product, which 
they have placed on the market, is not in conformity with the e ssential health and 
safety requirements set out in Annex III shall immediately take the corrective 
measures necessary to bring that machinery product into conformity, to withdraw it 
or recall it, as appropriate. Furthermore, where the machinery product pos es a risk to EN 35  EN the health and safety of persons and, where appropriate, domestic animals and 
property and, where applicable, the environment, importers shall immediately inform 
the competent national authorities  of the Member States in which they made the 
machinery product available on the market to that effect, giving details, in particular, 
of the non -conformity and of any corrective measures taken.  
8. Importers shall, for ten years after the machinery product has been placed on the 
market, keep a copy of t he EU declaration of conformity at the disposal of the market 
surveillance authorities  and ensure that the technical documentation can be made 
available to those authorities. Where relevant, the source code or programmed logic 
included in the technical doc umentation shall be made available upon a reasoned 
request from competent national authorities provided that it is necessary in order for 
those authorities to be able to check compliance with the essential health and safety 
requirements set out in Annex II I.  
9. Importers shall, further to a reasoned request from a competent national authority, 
provide it with all the information and documentation, in paper or electronic form, 
necessary to demonstrate the conformity of the machinery product with the essenti al 
health and safety requirements set out in Annex III in a language that can be easily 
understood by that authority. They shall cooperate with that authority, at its request, 
on any measures taken to eliminate the risks to the health and safety of persons  and, 
where appropriate, domestic animals and property and, where applicable, the 
environment  posed by a machinery product, which they have placed on the market.  
Article 13  
Obligations of distributors  
1. When making a machinery product available on the market, distributors shall act 
with due care in relation to the requirements of this Regulation.  
2. Before making a machinery product available on the market, distributors shall verify 
that: 
(a) the machinery product bears the CE marking;  
(b) the machinery  product is accompanied by the required documents and by the 
instructions and information set out in section  1.7 of Annex  III in a language 
which can be easily understood by end -users in the Member State in which the 
machinery product is to be made availab le on the market;  
(c) the manufacturer and the importer have complied with the requirements set out 
in Article  10(5) and  (6) and Article  12(3) respectively.  
3. Where a distributor considers or has reason to believe that a machinery product is not 
in confor mity with the essential health and safety requirements set out in Annex  III, 
the distributor shall not make the machinery product available on the market until it 
has been brought into conformity. Furthermore, where the machinery product poses a 
risk to th e health and safety of persons and, where appropriate, domestic animals and 
property and, where applicable, the environment, the distributor shall inform the 
manufacturer and the market surveillance authorities to that effect.  
4. Distributors shall ensure that, while a machinery product is under their responsibility, 
storage or transport conditions do not jeopardise its conformity with the essential 
health and safety requirements set out in Annex  III. EN 36  EN 5. Distributors who consider or have reason to believe t hat a machinery product, which 
they have made available on the market, is not in conformity with the essential health 
and safety requirements set out in Annex III shall make sure that the corrective 
measures necessary to bring that machinery product into c onformity, to withdraw it 
or recall it, as appropriate, are taken. Furthermore, where the machinery product 
poses a risk to the health and safety of persons and, where appropriate, domestic 
animals and property and, where applicable, the environment, distr ibutors shall 
immediately inform the competent national authorities of the Member States in 
which they have made the machinery product available on the market to that effect, 
giving details, in particular, of the non -conformity and of any corrective measur es 
taken.  
6. Distributors shall, further to a reasoned request from a competent national authority, 
provide it with all the information and documentation, in paper or electronic form, 
necessary to demonstrate the conformity of the machinery product with th e essential 
health and safety requirements set out in Annex III in a language that can be easily 
understood by that authority. They shall cooperate with that authority, at its request, 
on any measures taken to eliminate the risks to the health and safety o f persons and, 
where appropriate, domestic animals and property and, where applicable, the 
environment,  posed by a machinery product, which they have made available on the 
market.  
Article 14  
Cases in which obligations of manufacturers apply to importers a nd distributors  
An importer or distributor shall be considered a manufacturer for the purposes of this 
Regulation and shall be subject to the obligations of the manufacturer set out in Article  10 
where that importer or distributor places a machinery produc t on the market under his or her 
name or trademark or carries out a substantial modification of a machinery product that has 
already been placed on the market or put into service.  
Article 15  
Other cases in which obligations of manufacturers apply  
A natura l or legal person, other than the manufacturer, the importer or the distributor, that 
carries out a substantial modification of the machinery product shall be considered a 
manufacturer for the purposes of this Regulation and shall be subject to the obligat ions of the 
manufacturer set out in Article  10 for the part of the machinery product that is affected by the 
modification or, if the substantial modification has an impact on the safety of the machinery 
product as a whole, for the entire machinery product .  
Article 16  
Identification of economic operators  
1. Economic operators shall, on request, identify the following to the market 
surveillance authorities:  EN 37  EN (a) any economic operator who has supplied them with a machinery product;  
(b) any economic operator to  whom they have supplied a machinery product.  
2. Economic operators shall be able to present the information referred to in paragraph 
1 for ten years after they have been supplied with the machinery product and for ten 
years after they have supplied the ma chinery product.  
CHAPTER III  
CONFORMITY OF THE MACHINERY  
Article 17  
Presumption of conformity of machinery products  
1. A machinery product which is in conformity with harmonised standards or parts 
thereof the references of which have been published in the Official Journal of the 
European Union  shall be presumed to be in conformity with the essential health and 
safety requi rements set out in Annex III covered by those standards or parts thereof.  
2. The Commission shall, as provided in Article 10(1) of Regulation (EU) No 
1025/2012, request one or more European standardisation organisations to draft 
harmonised standards for the essential health and safety requirements set out in 
Annex III.  
3. The Comm ission is empowered to adopt implementing acts establishing technical 
specifications for the essential health and safety requirements set out in Annex III 
where the following conditions have been fulfilled:  
(a) no reference to harmonised standards coverin g the relevant essential health and 
safety requirements is published in the Official Journal of the European Union  
in accordance with Regulation (EU) No 1025/2012;  
(b) the Commission has requested one or more European standardisation 
organisations to draft  a harmonised standard for the essential health and safety 
requirements and there are undue delays in the standardisation procedure or the 
request has not been accepted by any of the European standardisation 
organisations.  
Those implementing acts shall be adopted in accordance with the examination 
procedure referred to in Article 46(3).  
4. A machinery product which is in conformity with the technical specifications or parts 
thereof shall be presumed to be in conformity with the essential health and safety 
requirements set out in Annex III covered by those technical specifications or parts 
thereof.  
5. Machinery products that have been certified or for which a statement of conformity 
has been issued under a cybersecurity scheme adopted in accordance with Reg ulation 
(EU) 2019/881 and the references of which have been published in the Official 
Journal of the European Union shall be presumed to be in conformity with the 
essential health and safety requirements set out in Annex III, sections 1.1.9 and 1.2.1, 
as regards protection against corruption and safety and reliability of control systems 
in so far as those requirements are covered by the cybersecurity certificate or 
statement of conformity or parts thereof.  EN 38  EN Article 18  
EU declaration of conformity  
1. The E U declaration of conformity shall state that the fulfilment of the applicable 
essential health and safety requirements set out in Annex III has been demonstrated.  
2. The EU declaration of conformity shall have the model structure set out in Annex V, 
shall  contain the elements specified in the relevant modules set out in Annexes VI, 
VII, VIII and IX and shall be continuously updated. It shall be translated into the 
language or languages required by the Member State in which the machinery product 
is placed o n the market or is made available on the market.  
3. Where a machinery product is subject to more than one Union act requiring an EU 
declaration of conformity, a single EU declaration of conformity shall be drawn up in 
respect of all such Union acts. That declaration shall contain the identification of the 
Union acts concerned, including their publication references.  
4. By drawing up the EU declaration of conformity, the manufacturer shall assume 
responsibility for the compliance of the machinery product w ith the requirements laid 
down in this Regulation.  
Article 19  
General principles of the CE marking  
The CE marking shall be subject to the general principles set out in Article 30 of Regulation 
(EC) No 765/2008.  
Article 20  
Rules for affixing the CE mar king  
1. The CE marking shall be affixed visibly, legibly and indelibly to the machinery 
product. Where that is not possible or not warranted on account of the nature of the 
machinery product, it shall be affixed to the packaging and to the documents 
accom panying the machinery product.  
2. The CE marking shall be affixed before the machinery product is placed on the 
market.  
3. For a machinery product in the conformity assessment of which a notified body 
participates in accordance with Annex IX, the CE mark ing shall be followed by the 
identification number of that notified body.  
The identification number of the notified body shall be affixed by the body itself or, 
under its instructions, by the manufacturer or the manufacturer’s authorised 
representative.  
4. The CE marking and, where applicable, the identification number of the notified 
body may be followed by a pictogram or other marking indicating a special risk or 
use.  EN 39  EN 5. Member States shall build upon existing mechanisms to ensure correct application o f 
the regime governing the CE marking and shall take appropriate action in the event 
of improper use of that marking.  
 
CHAPTER IV  
CONFORMITY ASSESSMENT  
Article 21  
Conformity assessment procedures for machinery products except partly completed 
machinery  
1. In order to certify the conformity of a machinery product with this Regulation, the 
manufacturer or its authorised representative and the person who has carried out a 
substantial modification to the machinery product, shall apply one of the procedures 
for assessment of conformity referred to in paragraphs 2 and 3.  
2. Where the machinery product is a high -risk machinery product listed in Annex I, the 
manufacturer or the manufacturer’s authorised representative and the person who has 
carried out a substant ial modification to the machinery product shall apply one of the 
following procedures:  
(a) EU type -examination procedure (module B) provided for in Annex VII, 
followed by conformity to type based on internal production control (module 
C) set out in Annex VIII;  
(b) Conformity based on full quality assurance (module H) set out in Annex IX.  
3. Where the machinery product is not a high -risk machinery product listed in Annex I, 
the manufacturer or the manufacturer’s authorised representative and the person who  
has made a substantial modification to the machinery product shall apply the internal 
production control procedure (module A) set out in Annex VI.  
4. Notified bodies shall take into account the specific interests and needs of small and 
medium sized enterp rises when setting the fees for conformity assessment and reduce 
those fees proportionately to their specific interests and needs.     
Article 22  
Conformity assessment procedures for partly completed machinery  
1. The manufacturer of partly completed machin ery or the manufacturer’s authorised 
representative shall, before placing partly completed machinery on the market, 
ensure that the following documents are drawn up:  
(a) the relevant technical documentation that satisfies the requirements laid down 
in Anne x IV, part B;  
(b) assembly instructions that satisfy the requirements laid down in Annex X;  
(c) the EU declaration of incorporation that has the model structure set out in 
Annex V.  EN 40  EN 2. Where relevant, the manufacturer of partly completed machinery or the 
manufacturer’s authorised representative shall make available to the competent 
national authority upon its request the source code or programmed logic included in 
the technical documentation referred to in paragraph 1, point (a), , provided that it is 
neede d in order for that authority to be able to check compliance with the essential 
health and safety requirements set out in Annex III. The assembly instructions 
referred to in paragraphs 1, point (b), and the declaration of incorporation referred to 
in parag raph 1, point (c), shall accompany the partly completed machinery until it is 
incorporated into the final machinery product and shall afterwards form part of the 
technical file for that machinery product.  
Article 23  
Protection of persons during installatio n and use of machinery products  
Member States may lay down requirements to ensure that persons, including workers, are 
protected when installing and using machinery products, provided that such rules do not allow 
for modification of a machinery product in a way that is not compatible with this Regulation.  
 
CHAPTER V  
NOTIFICATION OF CONFORMITY ASSESSMENT BODIES  
Article 24  
Notification  
Member States shall notify the Commission and the other Member States of conformity 
assessment bodies authorised to carry out conformity assessments in accordance with this 
Regulation.  
Article 25  
Notifying authorities  
1. Member States shall designate a notifying authority that shall be responsible for 
setting up and carrying out the necessary procedures for the assessment and 
notification of conformity assessment bodies and the monitoring of notified bodies, 
including compliance with Article 32.  
2. Member States may decide that the assessment and monitoring referred to in 
paragraph 1 shall be carried out by a national accr editation body within the meaning 
of and in accordance with Regulation (EC) No 765/2008.  
3. Where the notifying authority delegates or otherwise entrusts the assessment, 
notification or monitoring referred to in paragraph 1 of this Article to a body, whic h 
is not a governmental entity that body shall be a legal entity and shall comply mutatis 
mutandis  with the requirements laid down in Article 26. In addition, that body shall 
have arrangements to cover liabilities arising out of its activities.  EN 41  EN 4. The notifying authority shall take full responsibility for the tasks performed by the 
body referred to in paragraph 3.  
Article 26  
Requirements relating to notifying authorities  
1. A notifying authority shall be established in such a way that no conflict  of interest 
with conformity assessment bodies occurs.  
2. A notifying authority shall be organised and operated so as to safeguard the 
objectivity and impartiality of its activities.  
3. A notifying authority shall be organised in such a way that each dec ision relating to 
notification of a conformity assessment body is taken by competent persons different 
from those who carried out the assessment of the machinery product.   
4. A notifying authority shall not offer or provide any activities that conformity 
assessment bodies perform, or consultancy services on a commercial or competitive 
basis.  
5. A notifying authority shall safeguard the confidentiality of the information it obtains.  
6. A notifying authority shall have a sufficient number of competent pers onnel at its 
disposal for the proper performance of its tasks.  
Article 27  
Information obligation on notifying authorities  
Member States shall inform the Commission of their procedures for the assessment and 
notification of conformity assessment bodies a nd the monitoring of notified bodies, and of 
any changes thereto.  
The Commission shall make that information publicly available.  
Article 28  
Requirements relating to notified bodies  
1. For the purposes of notification, a conformity assessment body shall  meet the 
requirements laid down in paragraphs 2 to 11.  
2. A conformity assessment body shall be established under the national law of a 
Member State and have legal personality.  
3. A conformity assessment body shall be a third -party body independent of t he 
organisation or the machinery product it assesses.  
A body belonging to a business association or professional federation representing 
undertakings involved in the design, manufacture, provision, assembly, use or 
maintenance of machinery products which it assesses, may, on the condition that its 
independence and the absence of any conflict of interest are demonstrated, be 
considered such a conformity assessment body.  EN 42  EN 4. A conformity assessment body, its top -level management and the personnel 
responsible  for carrying out the conformity assessment tasks shall not be the 
designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of a  
machinery product, that they assess, nor the representative of any of those parties. 
This shall not p reclude the use of a machinery product that is necessary for the 
operations of the conformity assessment body or the use of a machinery product for 
personal purposes.  
A conformity assessment body, its top -level management and the personnel 
responsible for  carrying out the conformity assessment tasks shall not be directly 
involved in the design, manufacture, marketing, installation, use or maintenance of 
machinery products, or represent the parties engaged in those activities. They shall 
not engage in any a ctivity that may conflict with their independence of judgement or 
integrity in relation to conformity assessment activities for which they are notified. 
This shall in particular apply to consultancy services.  
A conformity assessment body shall ensure that  the activities of its subsidiaries or 
subcontractors do not affect the confidentiality, objectivity or impartiality of its 
conformity assessment activities.  
5. A conformity assessment body and its personnel shall carry out the conformity 
assessment activ ities with the highest degree of professional integrity and the 
requisite technical competence in the specific field and shall be free from all 
pressures and inducements, particularly financial, which might influence its 
judgement or the results of its con formity assessment activities, especially as regards 
persons or groups of persons with an interest in the results of those activities.  
6. A conformity assessment body shall be capable of carrying out all the conformity 
assessment activities mentioned in A nnexes VII, VIII and IX and in relation to which 
it has been notified, whether those tasks are carried out by the conformity assessment 
body itself or on its behalf and under its responsibility.  
At all times, and for each conformity assessment procedure a nd each kind of a 
machinery product for which it has been notified, a conformity assessment body shall 
have at its disposal the necessary:  
(a) personnel with technical knowledge and sufficient and appropriate experience 
to perform the conformity assessmen t activities;  
(b) descriptions of procedures in accordance with which conformity assessment is 
carried out, ensuring the transparency and the ability of reproduction of those 
procedures;  
(c) appropriate policies and procedures to distinguish between acti vities that it 
carries out as a notified body and other activities;  
(d) procedures for the performance of conformity assessment activities which take 
due account of the size of an undertaking, the sector in which it operates, its 
structure, the degree of complexity of the machinery technology in question 
and the mass or serial  nature of the production process.  
A conformity assessment body shall have the means necessary to perform the 
technical and administrative tasks connected with the conformity assessment 
activities in an appropriate manner and shall have access to all nece ssary equipment 
or facilities.  EN 43  EN 7. The personnel responsible for carrying out conformity assessment tasks shall have 
the following:  
(a) sound technical and vocational training covering all the conformity assessment 
activities in relation to which the conf ormity assessment body has been 
notified;  
(b) satisfactory knowledge of the requirements of the assessments they carry out 
and adequate authority to carry out those assessments;  
(c) appropriate knowledge and understanding of the essential health and safe ty 
requirements set out in Annex III, of the applicable harmonised standards 
referred to in Article 17, and of the relevant provisions of Union harmonisation 
legislation and of national legislation;  
(d) the ability to draw up certificates, records and reports demonstrating that 
conformity assessments have been carried out.  
8. The impartiality of a conformity assessment body, its top -level management and the 
personnel responsible for carrying out the conf ormity assessment activities shall be 
guaranteed.  
The remuneration of the top -level management and the personnel responsible for 
carrying out the conformity assessment activities shall not depend on the number of 
conformity assessments carried out or on t he results of those assessments.  
9. A conformity assessment body shall take out liability insurance unless liability is 
assumed by the Member State in accordance with national law, or the Member State 
itself is directly responsible for the conformity asse ssment.  
10. The personnel of a conformity assessment body shall observe professional secrecy 
with regard to all information obtained in carrying out the conformity assessment 
activities in accordance with Annexes VII, VIII and IX, except in relation to th e 
competent authorities of the Member State in which its activities are carried out. 
Proprietary rights, intellectual property rights and trade secrets shall be protected.  
11. A conformity assessment body shall participate in, or ensure that its personnel  
responsible for carrying out the conformity assessment activities are informed of, the 
relevant standardisation activities and the activities of the notified body coordination 
group established under Article 40 and shall apply as general guidance the 
admi nistrative decisions and documents produced as a result of the work of that 
group.  
Article 29  
Presumption of conformity of notified bodies  
Where a conformity assessment body demonstrates its conformity with the criteria laid down 
in the relevant harmoni sed standards or parts thereof the references of which have been 
published in the Official Journal of the European Union , it shall be presumed to comply with 
the requirements set out in Article 28 in so far as the applicable harmonised standards cover 
those requirements.  EN 44  EN Article 30  
Subsidiaries of and subcontracting by notified bodies  
1. Where a notified body subcontracts specific tasks connected with conformity 
assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or 
the sub sidiary meets the requirements set out in Article 28 and shall inform the 
notifying authority accordingly.  
2. A notified body shall take full responsibility for the tasks performed by 
subcontractors or subsidiaries wherever those are established.  
3. Activities may be subcontracted or carried out by a subsidiary only with the 
agreement of the client.  
4. A notified body shall keep at the disposal of the notifying authority the relevant 
documents concerning the assessment of the qualifications of the subcon tractor or the 
subsidiary and the work carried out by them under Annexes VII, VIII and IX.  
Article 31  
Application for notification  
1. A conformity assessment body shall submit an application for notification to the 
notifying authority of the Member Stat e in which it is established.  
2. The application for notification shall be accompanied by a description of the 
conformity assessment activities, of the conformity assessment procedures set out in 
Annexes VII, VIII and IX and of the kind of machinery produ ct for which the 
conformity assessment body claims to be competent, as well as by an accreditation 
certificate, where one exists, issued by a national accreditation body attesting that the 
conformity assessment body fulfils the requirements laid down in Ar ticle 28.  
3. Where the conformity assessment body concerned cannot provide an accreditation 
certificate as referred to in paragraph 2, it shall provide the notifying authority with 
all the documentary evidence necessary for the verification, recognition a nd regular 
monitoring of its compliance with the requirements laid down in Article 28.  
Article 32  
Notification procedure  
1. A notifying authority shall notify only conformity assessment bodies which have 
satisfied the requirements laid down in Article 28.  
2. The notifying authority shall send a notification to the Commission and the other 
Member States of each conformity asses sment body referred to in paragraph 1, using 
the electronic notification tool developed and managed by the Commission.  
3. The notification referred to in paragraph 2 shall include the following:  
(a) full details of the conformity assessment activities to  be performed;  
(b) an indication of the conformity assessment module or modules and the kinds of 
machinery products concerned;  EN 45  EN (c) the relevant attestation of competence.   
4. Where a notification is not based on an accreditation certificate referred to in Article 
31(2), the notifying authority shall provide the Commission and the other Member 
States with documentary evidence which attests to the conformity assessment body's 
competence and the arrangements in place to ensure that that body will be monitor ed 
regularly and will continue to satisfy the requirements laid down in Article 28.   
5. The conformity assessment body concerned may perform the activities of a notified 
body only where no objections are raised by the Commission or the other Member 
States  within two weeks of the validation of the notification where it includes an 
accreditation certificate referred to in Article 31(2), or within two months of the 
notification where it includes documentary evidence referred to in Article 31(3).  
Only such a body shall be considered a notified body for the purposes of this 
Regulation.  
6. The notifying authority shall notify the Commission and the other Member States of 
any subsequent relevant changes to the notification referred to in paragraph 2.  
Article 33   
Identification numbers and lists of notified bodies  
1. The Commission shall assign an identification number to a notified body.  
It shall assign a single such number even where the body is notified under several 
Union acts.  
2. The Commission shall make publicly available the list of notified bodies including 
the identification numbers that have been assigned to them and the conformity 
assessment activities for which they have been notified.  
The Commission shall ensure that the list is kept up to date.  
Article 34  
Changes to notifications  
1. Where a notifying authority has ascertained or has been informed that a notified body 
no longer meets the requirements laid down in Article 28, or that it is failing to fulfil 
its obligatio ns as set out in Article 35 the notifying authority shall restrict, suspend or 
withdraw the notification, as appropriate, depending on the seriousness of the failure 
to meet those requirements or fulfil those obligations. It shall immediately inform the 
Commission and the other Member States accordingly.  
2. In the event of restriction, suspension or withdrawal of notification, or where the 
notified body has ceased its activity, the notifying authority shall take appropriate 
steps to ensure that the files o f that body are either processed by another notified 
body or kept available for the responsible notifying and market surveillance 
authorities at their request.  EN 46  EN Article 35  
Challenge of the competence of notified bodies  
1. The Commission shall investigate  all cases where it doubts, or doubt is brought to its 
attention regarding, the competence of a notified body or the continued fulfilment by 
a notified body of the requirements and responsibilities to which it is subject.  
2. The notifying authority shall provide the Commission, on request, with all 
information relating to the basis for the notification or the maintenance of the 
competence of the notified body concerned.  
3. The Commission shall ensure that all sensitive information obtained in the course o f 
its investigations is treated confidentially.  
4. Where the Commission ascertains that a notified body does not meet or no longer 
meets the requirements for its notification, it shall adopt an implementing act 
requesting the notifying authority to take t he necessary corrective measures, 
including the withdrawal of the notification if necessary.  
That implementing act shall be adopted in accordance with the advisory procedure 
referred to in Article 46(2).  
Article 36  
Operational obligations of notified bodies  
1. A notified body shall carry out conformity assessments in accordance with the 
conformity assessment procedures set out in Annexes VII, VIII and IX.  
2. A notified body shall perform its activities in a proport ionate manner, avoiding 
unnecessary burdens for economic operators, and taking due account of the size of an 
undertaking, the sector in which the undertaking operates, the structure of the 
undertaking, the degree of complexity of the machinery technology i n question and 
the mass or serial nature of the production process.  
In so doing, the notified body shall nevertheless respect the degree of rigour and the 
level of protection required for the compliance of the machinery product with the 
requirements of th is Regulation.  
3. Where a notified body finds that the essential health and safety requirements set out 
in Annex III, or the harmonised standards referred to in Article 17, or other technical 
specifications have not been met by a manufacturer, it shall re quire the manufacturer 
to take appropriate corrective measures and shall not issue a certificate  of conformity 
or adopt an approval decision  
4. Where, in the course of the monitoring of conformity following the issuance of a 
certificate of conformity or t he adoption of an approval decision, a notified body 
finds that a machinery product no longer complies, it shall require the manufacturer 
to take appropriate corrective measures and shall suspend or withdraw the certificate 
of conformity or the approval de cision, if necessary.  
5. Where corrective measures are not taken or do not have the required effect, the 
notified body shall restrict, suspend or withdraw any certificates of conformity or 
approval decisions, as appropriate.  EN 47  EN Article 37  
Appeals against d ecisions of notified bodies  
A notified body shall ensure that a transparent and accessible appeals procedure against its 
decisions is available.  
Article 38  
Information obligation on notified bodies  
1. A notified body shall inform the notifying authorit y of the following:  
(a) any refusal, restriction, suspension or withdrawal of a certificate of conformity 
or approval decision;  
(b) any circumstances affecting the scope of, or the conditions for, its notification;  
(c) any request for information which it has received from market surveillance 
authorities regarding its conformity assessment activities;  
(d) on request, any conformity assessment activities performed within the scope of 
its notification and any other activity performed, including cross -border 
activities and subcontracting.  
2. A notified body shall provide other notified bodies carrying out similar conformity 
assessment activities covering the same kinds of machinery product with relevant 
information on issues relating to negative and, on re quest, positive conformity 
assessment results.  
Article 39  
Exchange of experience  
The Commission shall provide for the organisation of exchange of experience between the 
Member States' national authorities responsible for notification policy.  
Article 40  
Coordination of notified bodies  
The Commission shall ensure that appropriate coordination and cooperation between notified 
bodies are put in place and properly operated in the form of a sectoral group of notified 
bodies.  
A notified body shall  participate in the work of that group, directly or by means of designated 
representatives.  
CHAPTER VI  
UNION MARKET SURVEILLANCE, CONTROL OF MACHINERY PRODUCTS 
ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE  
 EN 48  EN Article 41  
Procedure at national level for dealing with machinery products presenting a risk  
1. Where the market surveillance authorities of one Member State have sufficient 
reason to believe that a machinery product covered by this Regulation presents a risk 
to the  health or safety of persons, and, where appropriate, domestic animals or to 
property and, where applicable, the environment, they shall carry out an evaluation in 
relation to the machinery product concerned covering all relevant requirements laid 
down in this Regulation. The relevant economic operators shall cooperate as 
necessary with the market surveillance authorities for that purpose.  
Where, in the course of the evaluation referred to in the first subparagraph, the 
market surveillance authorities find  that the machinery product does not comply with 
the requirements laid down in this Regulation, they shall without delay require the 
relevant economic operator to take all appropriate corrective action to bring the 
machinery product into compliance with th ose requirements, to withdraw the 
machinery product from the market, or to recall it within a reasonable period which is 
commensurate with the nature of the risk referred to in the first subparagraph.  
The market surveillance authorities shall inform the r elevant notified body 
accordingly.  
2. Where the market surveillance authorities consider that non -compliance is not 
restricted to their national territory, they shall inform the Commission and the other 
Member States of the results of the evaluation and o f the actions which they have 
required the economic operator to take.  
3. The economic operator shall ensure that all appropriate corrective action is taken in 
respect of all the machinery products concerned that the economic operator has made 
available on  the market throughout the Union.   
4. Where the relevant economic operator does not take adequate corrective action 
within the period referred to in paragraph 1, second subparagraph, the market 
surveillance authorities shall take all appropriate provision al measures to prohibit or 
restrict the machinery product being made available on their national market, to 
withdraw the machinery product from that market or to recall it.  
The market surveillance authorities shall inform the Commission and the other 
Memb er States, without delay, of those measures.  
5. The information referred to in paragraph 4, second subparagraph, shall include all 
available details, in particular the data necessary for the identification of the non -
compliant machinery product, the origi n of that machinery product, the nature of the 
non-compliance alleged and the risk involved, the nature and duration of the national 
measures taken and the arguments put forward by the relevant economic operator. In 
particular, the market surveillance auth orities shall indicate whether the non -
compliance is due to any of the following:  
(a) failure of the machinery product to meet the requirements relating to the 
essential health and safety requirements set out in Annex III;   
(b) shortcomings in the harmon ised standards referred to in Article 17(1);  
(c) shortcomings in the technical specifications referred to in Article 17(4).  EN 49  EN 6. Member States other than the Member State initiating the procedure under this 
Article shall without delay inform the Commission and the other Member States of 
any measures adopted and of any additional information at their disposal relating to 
the non -compliance of the machinery product concerned, and, in the event of 
disagreement with the adopted national measure, of their objecti ons.  
7. Where, within three months of receipt of the information referred to in paragraph 4, 
second subparagraph, no objection has been raised by either a Member State or the 
Commission in respect of a provisional measure taken by a Member State, that 
measure shall be deemed justified.  
8. Member States shall ensure that appropriate restrictive measures, such as withdrawal 
of the machinery product from the market, are taken in respect of the machinery 
product concerned without delay.  
Article 42  
Union saf eguard procedure  
1. Where, on completion of the procedure set out in Article 41(3) and (4), objections 
are raised against a measure taken by a Member State, or where the Commission 
considers a national measure to be contrary to Union legislation, the Comm ission 
shall without delay enter into consultation with the Member States and the relevant 
economic operator or operators and shall evaluate the national measure. On the basis 
of the results of that evaluation, the Commission shall adopt an implementing ac t in 
the form of a decision determining whether the national measure is justified or not.  
The Commission shall address its decision to all Member States and shall without 
delay communicate it to them and to the relevant economic operator or operators.  
That implementing act shall be adopted in accordance with the examination 
procedure referred to in Article 46(3).  
2. If the national measure is considered justified, all Member States shall take the 
necessary measures to ensure that the non -compliant machin ery product is 
withdrawn from their market, and shall inform the Commission accordingly.  
If the national measure is considered unjustified, the Member State concerned shall 
withdraw that measure.  
3. Where the national measure is considered justified and the non -compliance of the 
machinery product is attributed to shortcomings in the harmonised standards or 
technical specifications referred to in Article 41(5), points (b) and (c), of this 
Regulation, t he Commission shall apply the procedure provided for in Article 11 of 
Regulation (EU) No 1025/2012.  
Article 43  
Compliant machinery products which present a risk  
1. Where, having carried out an evaluation under Article 41(1), a Member State finds 
that al though a machinery product is in compliance with the essential health and 
safety requirements set out in Annex III, it poses a risk to the health and safety of 
persons and, where appropriate, domestic animals or to property and, where EN 50  EN applicable, the envir onment, it shall require the relevant economic operator to take 
all appropriate measures to ensure that the machinery product concerned, when 
placed on the market, no longer presents that risk, to withdraw the machinery product 
from the market or to recall  it within a reasonable period which is commensurate 
with the nature of the risk.  
2. The economic operator shall ensure that corrective action is taken in respect of all the 
machinery products concerned that the economic operator has made available on the 
market throughout the Union.  
3. The Member State shall immediately inform the Commis sion and the other Member 
States. That information shall include all available details, in particular the data 
necessary for the identification of the machinery product concerned, the origin and 
the supply chain of the machinery product, the nature of the risk involved and the 
nature and duration of the national measures taken.  
4. The Commission shall without delay enter into consultation with the Member States 
and the relevant economic operator or operators and shall evaluate the national 
measures taken. O n the basis of the results of that evaluation, the Commission shall 
adopt an implementing act in the form of a decision determining whether the national 
measure is justified or not and, where necessary,  order  appropriate measures.  
That implementing act shall be adopted in accordance with the examination 
procedure referred to in Article 46(3).  
On duly justified imperative grounds of urgency relating to the protection of the 
health and safety of persons, the Commission shall adopt an immediately applicabl e 
implementing act in accordance with the procedure referred to in Article 46(4).  
5. The Commission shall address its decision to all Member States and shall 
immediately communicate it to them and to the relevant economic operator or 
operators.  
Article 4 4  
Formal non -compliance  
1. Without prejudice to Article 41, where a Member State makes one of the following 
findings with regard to a machinery product, it shall require the relevant economic 
operator to put an end to the non -compliance concerned:  
(a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) 
No 765/2008 or of Article 20 of this Regulation;  
(b) the CE marking has not been affixed;  
(c) the identification number of the notified body involved in the production 
control p hase has been affixed in violation of Article 20(3) or has not been 
affixed;  
(d) the EU declaration of conformity has not been drawn up or has not been drawn 
up correctly;  
(e) the technical documentation is either not available or not complete;  
(f) the information referred to in Article 10(6) or Article 12(3) is absent, false or 
incomplete;  EN 51  EN (g) any other administrative requirement provided for in Article 10 or Article 12 is 
not fulfilled.  
2. Where the non -compliance referred to in paragraph 1 persists,  the Member State 
concerned shall take all appropriate measures to restrict or prohibit the machinery 
product being made available on the market or ensure that it is recalled or withdrawn 
from the market.  
CHAPTER VII  
DELEGATED POWERS AND COMMITTEE PROCED URE  
Article 45  
Exercise of the delegation  
1. The power to adopt delegated acts is conferred on the Commission subject to the 
conditions laid down in this Article.  
2. The power to adopt delegated acts referred to in Articles 5(2) and 6(2) shall be 
confer red on the Commission for a period of five years from … [ the date of entry 
into force of this Regulation ]. The Commission shall draw up a report in respect of 
the delegation of power not later than nine months before the end of the five -year 
period. The de legation of power shall be tacitly extended for periods of an identical 
duration, unless the European Parliament or the Council opposes such extension not 
later than three months before the end of each period.  
3. Before adopting a delegated act, the Commi ssion shall consult experts designated by 
each Member State in accordance with the principles laid down in the 
Interinstitutional Agreement of 13 April 2016 on Better Law -Making.  
4. The delegation of powers referred to in Articles 5(2) and 6(2) may be revoked at any 
time by the European Parliament or by the Council. A decision to revoke shall put an 
end to the delegation of the power specified in that decision. It shall take effect th e 
day following the publication of the decision in the Official Journal of the European 
Union  or at a later date specified therein. It shall not affect the validity of any 
delegated acts already in force.  
5. As soon as it adopts a delegated act, the Commi ssion shall notify it simultaneously to 
the European Parliament and to the Council.  
6. A delegated act adopted pursuant to Articles 5(2) and 6(2) shall enter into force only 
if no objection has been expressed either by the European Parliament or the Counc il 
within a period of two months of notification of that act to the European Parliament 
and the Council or if, before the expiry of that period, the European Parliament and 
the Council have both informed the Commission that they will not object. That 
perio d shall be extended by two months at the initiative of the European Parliament 
or of the Council.  EN 52  EN Article 46  
Committee procedure  
1. The Commission shall be assisted by a committee. That committee shall be a 
committee within the meaning of Regulation (EU) No 182/2011.  
2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 
182/2011 shall apply.  
3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 
182/2011 shall apply.  
4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 
182/2011, in conjunction with Article 5 thereof, shall apply.  
5. The committee shall be consulted  by the Commission on any matter for which 
consultation of sectoral experts is required by Regulation (EU) No 1025/2012 or by 
any other Union legislation.  
The committee may furthermore examine any other matter concerning the 
application of this Regulation  raised either by its chair or by a representative of a 
Member State in accordance with its rules of procedure.  
 
CHAPTER VIII  
CONFIDENTIALITY AND PENALTIES  
Article 47  
Confidentiality  
1. All parties shall respect the confidentiality of the following inf ormation and data 
obtained in carrying out their tasks in accordance with this Regulation:  
(a) personal data;  
(b) commercially confidential information and trade secrets of a natural or legal 
person, including intellectual property rights, unless disclosu re is in the public 
interest.  
2. Without prejudice to paragraph  1, information exchanged on a confidential basis 
between the competent national authorities and between competent national 
authorities and the Commission shall not be disclosed without the pri or agreement of 
the originating competent national authority.  
3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, 
Member  States and notified bodies with regard to the exchange of information and 
the dissemination of warning s, nor the obligations of the persons concerned to 
provide information under criminal law.  
4. The Commission and Member  States may exchange confidential information with 
regulatory authorities of third countries with which they have concluded bilateral or 
multilateral confidentiality arrangements.  EN 53  EN Article 48  
Penalties  
1. Member States shall lay down the rules on penalties applicable to infringements by 
economic operators of this Regulation and shall take all measures necessary to 
ensure that they are enfor ced. The penalties provided for shall be effective, 
proportionate and dissuasive and may include criminal penalties for serious 
infringements.  
2. Member States shall notify those rules and those measures to the Commission by … 
[24 months after the date of  entry into force of this Regulation ] and shall notify it 
without delay of any subsequent amendment affecting them.  
 
CHAPTER IX  
TRANSITIONAL AND FINAL PROVISIONS  
Article 49   
Repeals  
1. Directive 73/361/EEC is repealed.  
References to the repealed Directive 73/361/EEC shall be construed as references to 
this Regulation.   
2. Directive 2006/42/EC is repealed with effect from … [30 months after the date of 
entry into force of this Regulation].  
References to the repealed Dire ctive 2006/42/EC shall be construed as references to 
this Regulation and shall be read in accordance with the correlation table in Annex 
XI.  
Article 50  
Transitional provisions  
1. Member States shall not until … [ 42 months after the date of entry into for ce of this 
Regulation ] impede the making available on the market of machinery which was 
placed on the market in conformity with Directive 2006/42/EC before … [ the date of 
entry into force of this Regulation ]. However, Chapter VI of this Regulation shall 
apply mutatis mutandis  to such machinery instead of Article 11 of that Directive, 
including machinery for which a procedure has already been initiated under Article 
11 of Directive 2006/42/EC as from … [ the date of entry into force of this 
Regulation ]. 
2. EC type-examination certificates and approval decisions issued in accordance with 
Article 14 of Directive 2006/42/EC shall remain valid until … [ 42 months after the 
date of entry into force of this Regulation ], unless they expire before that date.  EN 54  EN Article 5 1  
Evaluation and review  
1. By … [54 months after the date of entry into force of this Regulation ] and every four 
years thereafter, the Commission shall submit a report on the evaluation and review 
of this Regulation to the European Parliament and to the Council. The reports shall 
be made public.  
2. Taking account of technical progress and practical experience gained in Member 
States as indicated in Article 5, the Commission shall in its report include an 
evaluation on the following aspects of this Regula tion:  
(a) the essential health and safety requirements set out in Annex III;  
(b) the conformity assessment procedure applicable to high -risk machinery 
products listed in Annex I.  
Where appropriate, the report shall be accompanied by a legislative propos al for 
amendment of the relevant provisions of this Regulation.  
Article 52  
Entry into force and application  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
It sha ll apply from … [30 months after the date of entry into force of this Regulation].    
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
For the European Parliament  For the Council